Type2 Diabetes MellitusNCT03830840
Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos
An observational study of Type2 Diabetes Mellitus and Cardiovascular Diseases, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, including children and youth, and measuring the 5 determinants of human health: genetics, biology, behavior, psychology, and society/environment. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 29 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Up to 1,200 families may be screened and enrolled with the prediction of 20% screen-fail or dropout and 1,000 families enrolled in the study. A "family" will be followed as one unit but is estimated to include on average 3 to 5 individuals based on the findings from the Operational Pilot. Up to 6,000 individuals may be enrolled in this study.
Who may be able to join
- Males or females ≥ 7 years of age at enrollment.
- Self-reported Latino heritage.
- Co-resides with immediate family member (as defined above) OR self with established diagnosis of Type 2 Diabetes for at least one year prior to enrollment date.
- Signed and dated written informed consent by the date of enrollment.
- Based on the research staff's judgment, subject or subject's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion.
- -
Who cannot join
- Life expectancy < 6 months.
- Any active clinically significant physical or mental disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
- Language barriers precluding comprehension of study activities and informed consent.
- Participation in other trials involving medication or device within 1 month prior to enrollment.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Mil Familias: an Observational Cohort Study to Understand the Impact of Genetics, Biology, Behavior, Psychology, and Society/Environment on Diabetes and Its Complications Among US Latinos
The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, including children and youth, and measuring the 5 determinants of human health: genetics, biology, behavior, psychology, and society/environment.
Read the detailed description
The vision of Mil Familias is to reduce the burden of cardio-metabolic disease among Latino families in Santa Barbara County and beyond. The aim is to establish an observational cohort of 1,000 Latino families, with at least one family member currently living with diabetes, in order to understand better the impact of the 5 determinants of human health (genetics, biology, behavior, psychology, and society/environment) in this population. Once the 1,000-family cohort is established, evidence-based intervention studies will be developed and implemented based on new knowledge, with collaborators from the healthcare, public policy, academic, pharmaceutical, medical device and technology industries. The strategy involves 4 coordinated and iterative components to achieve its mission:
- Especialistas: Trusted, bilingual community health workers specially-trained in diabetes education, clinical research methodologies, and care referral. The Especialistas will engage directly with participants to conduct research activities, answer questions, and when necessary, refer participants to appropriate, local community resources.
- Data: Facilitated by Especialistas, each individual participant will contribute information on up to 100 different variables relating to their genetics, biology, psychology, behavior and society/environment, thus creating a one-of-a-kind database and associated specimen biobank on Latino health and lifestyle ("Living Information Bank").
- Interventions: Based on the data, evidence-based, collaborative, culturally-relevant prevention and treatment strategies are planned to develop once the cohort of 1,000 families has been established.
- Allies: This community-based participatory research study requires engagement from key stakeholders from the Latino community, healthcare sectors, hospitals, payers, businesses, people with diabetes and philanthropists. Organizations and individuals support Mil Familias by contributing their resources, experiences, and skill-sets.
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Type 2 diabetes, Cardio-metabolic disease, Latino/Hispanic, Especialista, Community health worker, Social determinants of health, LatinX
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Individuals with Type 2 diabetes | Individuals ≥18 years of Hispanic/Latino heritage with an established diagnosis of type 2 diabetes | |
| Adult Family member | Adult family members, ≥18 years, of the individual with type 2 diabetes | |
| Child family member with diabetes | Child, ≥7 years but <18 years, family member with diabetes | |
| Child family member without diabetes | Child, ≥7 years but <18 years, family member without diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot.
The Mil Familias Cohort Establishment will expand upon the Mil Familias Operational Pilot cohort and infrastructure to collect and store the up to 100 proposed variables across the 5 determinants of human health to support long-term Mil Familias implementation. The variables pertaining to each participant will be collected and stored at the initial visit and then annually for up to 3 years. Socio-demographic characteristics of the cohort will be described at enrollment by type 2 diabetes status, including age, gender, self-identified race/ethnicity, number of people in household, education, insurance, income, occupation, HbA1c, and country of birth.
Measured: 3 years
Secondary outcomes (57)
Socio-demographics assessed by questionnaire.
Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, number in household, income, education, marital status, occupation, caring for elder, night shifts, insurance status, insurance type and payer, influenza immunization status, immigration status, alcohol \& tobacco use, birth place,and duration of time in the United States (<5 years, 5-9 years, 10-14 years, 15-19 years, 20-24 years, ≥25 years).
Measured: Introductory interview/ demographics/ contacts and annually up to 3 years
Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire
Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by interview questionnaire
Measured: Introductory interview/ demographics/ contacts and annually up to 3 years
Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
Personal opinion regarding type 2 diabetes burden on Latinos measured by 3 questions - why is diabetes common in Latinos, what can be done to prevent diabetes in Latinos, and what things make it difficult to get help with diabetes when it is needed?
Measured: Introductory interview/ demographics/ contacts and annually up to 3 years
Total daily tortilla consumption
The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated
Measured: Introductory interview/ demographics/ contacts and annually up to 3 years
Daily sugary drink consumption
Daily sugary drink consumption is measured by the 2 questions in the Sugar Sweetened Beverages module of the Behavioral Risk Factor Surveillance System Questionnaire from the Centers for Disease Control.
Measured: Introductory interview/ demographics/ contacts and annually up to 3 years
Number of times per week eating meals prepared away from home
NHANES 2017-2018 question asked - During the past 7 days, how many meals did you get that were prepared away from home in places such as restaurants, fast food places, food stands, grocery stores, or from vending machines?
Measured: Introductory interview/ demographics/ contacts and annually up to 3 years
Laboratory blood draw for evaluation of C-Peptide related to diabetes
C-Peptide, ng/mL, will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of C-Reactive protein related to diabetes
C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Complete Blood Count
Complete Blood Count will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Comprehensive Metabolic Panel
Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes
Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of HbA1c related to diabetes
HbA1c % will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes
Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes
Islet antigen 2 (IA-2) antibody, U/mL, will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of lipids
Lipids will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Insulin
Insulin, milliunits/L, will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of thyroid function
Thyroid function will measured in a laboratory blood draw sample.
Measured: Laboratory encounter and annually up to 3 years
Microalbumin measured in a urine sample
Urine sample collected for measuring microalbumin mg/L
Measured: Laboratory encounter and annually up to 3 years
Creatinine measured in a urine sample
Urine sample collected for measuring creatinine
Measured: Laboratory encounter and annually up to 3 years
Microalbumin/creatinine ratio measured in a urine sample
Urine sample collected for measuring the microalbumin/creatinine ratio
Measured: Laboratory encounter and annually up to 3 years
Cheek cells and saliva for genomic analysis
Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis
Measured: Laboratory encounter and annually up to 3 years
Stool samples for microbiome analysis
Stool/fecal samples will be collected for microbiome analysis
Measured: Laboratory encounter and annually up to 3 years
Height measured by Physical exam
Height measured in centimeters or inches by physical exam
Measured: Physical exam encounter and annually up to 3 years
Weight measured by Physical exam
Weight measured in kilograms or pounds by physical exam
Measured: Physical exam encounter and annually up to 3 years
Waist circumference measured by Physical exam
Waist circumference measured in centimeters or inches by physical exam
Measured: Physical exam encounter and annually up to 3 years
Blood pressure measured by Physical exam
Blood pressure, systolic and diastolic, measured in mmHg by physical exam
Measured: Physical exam encounter and annually up to 3 years
Temperature measured by Physical exam
Temperature measured in degrees by physical exam
Measured: Physical exam encounter and annually up to 3 years
Heart rate measured by Physical exam
Heart rate measured in beats per minute by physical exam
Measured: Physical exam encounter and annually up to 3 years
Foot examination evaluated by Questions and Physical exam
Foot examination with yes or no questions and by physical exam
Measured: Physical exam encounter and annually up to 3 years
Neuropathy Questions during Physical exam
Questions about neuropathy
Measured: Physical exam encounter and annually up to 3 years
Retinopathy questions during Physical exam
Questions about retinopathy
Measured: Physical exam encounter and annually up to 3 years
Dental exam Questions during Physical exam
Questions about dental exams
Measured: Physical exam encounter and annually up to 3 years
Eye exam Questions during Physical exam
Questions about eye exams
Measured: Physical exam encounter and annually up to 3 years
Medical history, family medical history, and medication status and history assessed by interview
Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire
Measured: Physical exam encounter and annually up to 3 years
Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview
Menopausal status, pregnancy status (number of live births, number of stillbirths, birthweights of live births, and any diagnosis of type 1 diabetes), and gestational diabetes history for female participants will be determined by interview
Measured: Physical exam encounter and annually up to 3 years
Determination of diabetes related foot disease
Questionnaire for determination of diabetes related foot disease (Q-DFD)
Measured: Questionnaires encounter and annually up to 3 years
Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
BASH is a participant reported questionnaire to measure acculturation. Responses are scored as 1 = only Spanish, 2 = Spanish more than English, 3 = Spanish and English equally, 4 = English more than Spanish, and 5 = only English. Items are summed and divided by the number of items. Low acculturation is less than or equal to 3.0, and high acculturation is greater than or equal to 3.0.
Measured: Questionnaire encounter and annually up to 3 years
Quality of life measured by the Short Form Health Survey (SF-12)
The SF-12 is a participant reported questionnaire to measure quality of life
Measured: Questionnaires encounter and annually up to 3 years
Depression measured by the Patient Health Questionnaire-9
The Patient Health Questionnaire (PHQ)-9 is the Major Depressive Disorder (MDD) module of the full PHQ
Measured: Questionnaires encounter and annually up to 3 years
Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)
PEDQ-CV is a participant reported questionnaire to measure perceived ethnic discrimination
Measured: Questionnaires encounter and annually up to 3 years
Adverse Childhood Experiences (ACE) quantified by ACE questionnaire
Adverse Childhood Experiences (ACEs) refers to a range of events that a child can experience, which lead to stress and can result in trauma and chronic stress responses. An ACE score will be quantified by a specific ACE questionnaire.
Measured: Questionnaires encounter and annually up to 3 years
Spirituality measured by a Spiritual Well Being Scale
FACIT" (Functional Assessment of Chronic Illness Therapy) Sp-12 is a questionnaire for measuring spiritual well being. Questions are scored from 0 = Not at all to 4 = Very much. Sub-scales are created for meaning, peace, and faith with score ranges of 0 - 16. Adding these 3 scores gives a total score and the range is 0 - 48 with low scores indicating low spiritual well being and high scores indicating higher spiritual well being.
Measured: Questionnaires encounter and annually up to 3 years
Risk Perception Survey For Developing Diabetes (RPS-DD)
Diabetes risk perception will be measured by the Risk Perception Survey For Developing Diabetes (RPS-DD)
Measured: Questionnaires encounter and annually up to 3 years
Sleep quality measured by the Oviedo Sleep Questionnaire (OSQ)
The OSQ is a participant reported questionnaire to measure sleep quality
Measured: Questionnaires encounter and annually up to 3 years
Stress measured by the 4 item Perceived Stress Scale (PSS)
PSS is a participant reported questionnaire to measure stress. The scale ranges from 0 = never to 4 = very often. The final score ranges from 0 - 16, with higher scores indicating more stress.
Measured: Questionnaires encounter and annually up to 3 years
Drug abuse measured by the Drug Abuse Screening Test (DAST) - 20
The purpose of the DAST-20 is to provide a brief, simple, practical, but valid method for identifying individuals who are abusing psychoactive drugs; and to yield a quantitative index score of the degree of problems related to drug use and misuse
Measured: Questionnaires encounter and annually up to 3 years
Diabetes management measured by the Diabetes Symptom Self-Care Inventory
Ability to manage diabetes self-care assessed by the Diabetes Symptom Self-Care Inventory (DSSCI)
Measured: Questionnaires encounter and annually up to 3 years
Family diabetes management measured by questionnaire
Family diabetes Self-Efficacy for management of diabetes measured by questionnaire (FSE)
Measured: Questionnaires encounter and annually up to 3 years
Foot self care confidence measured by questionnaire
Foot Care Confidence Scale (FCCS) is an instrument designed to measure the confidence (self-efficacy) of individuals with type 2 diabetes to perform foot self care
Measured: Questionnaires encounter and annually up to 3 years
Health literacy measured by the Short Assessment of Health Literacy (SAHL)
SAHL is a participant reported questionnaire to measure health literacy
Measured: Questionnaires encounter and annually up to 3 years
Measurement of health numeracy
Newest Vital Sign (NVS) is a tool to assess health literacy and numeracy in English and Spanish
Measured: Questionnaires encounter and annually up to 3 years
Trust in physician measured by the Trust in Physician (TPS) questionnaire
The TPS is a questionnaire and scale to determine trust in the physician
Measured: Questionnaires encounter and annually up to 3 years
Social needs screening assessed by the Health Leads Screening toolkit
The Health Leads Screening tookit (Boston, MA) will be used to determine social needs - housing instability, childcare, utility needs, financial resource strain, transportation, and exposure to violence.
Measured: Questionnaires encounter and annually up to 3 years
Food security assessed by U.S. Household Food Security Survey Module: Six-item short form
Food security or insecurity assessed by a six-item short form developed by the Economic Research Service, United States Department of Agriculture (USDA), September 2012
Measured: Questionnaires encounter and annually up to 3 years
Functional support measured by the SSQ6
Social Support Questionnaire - Short Form (SSQ6) measures functional social support
Measured: Questionnaires encounter and annually up to 3 years
Support structure measured by Medical Outcomes Study Social Support Survey (mMOS-SS)
The eight-item modified Medical Outcomes Study Social Support Survey (mMOS-SS) measures support structure by counting the number of people supporting and satisfaction with that support
Measured: Questionnaires encounter and annually up to 3 years
National survey of children's health (NSCH) for all children and youth
The NSCH, a validated survey of children's health and translated into Spanish, will assess health of children and youth
Measured: Questionnaires encounter and annually up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Feb 2019
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- David Kerr, MBChB DM FRCP, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830840
- Sponsor's protocol ID
- 2017 - 6004
- Status last verified
- Jun 2022
- First submitted
- 22 Jan 2019
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in publications.
Publications
Kerr D, Abbasi M, Bevier W, Glantz N, Larez A, Sabharwal A. Patterns of Timing and Intensity of Physical Activity and HbA1c Levels in Hispanic/Latino Adults With or at Risk of Type 2 Diabetes. J Diabetes Sci Technol. 2024 Jan;18(1):106-112. doi: 10.1177/19322968221105531. Epub 2022 Jun 30.
PubMed 35771029Morales J, Glantz N, Larez A, Bevier W, Conneely M, Fan L, Reed B, Alatorre C, Paczkowski R, Ahmed T, Mackenzie A, Duncan I, Kerr D. Understanding the impact of five major determinants of health (genetics, biology, behavior, psychology, society/environment) on type 2 diabetes in U.S. Hispanic/Latino families: Mil Familias - a cohort study. BMC Endocr Disord. 2020 Jan 6;20(1):4. doi: 10.1186/s12902-019-0483-z.
PubMed 31906923
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mil Familias: an Observational Cohort Study to Understand the Impact of Genetics, Biology, Behavior, Psychology, and Society/Environment on Diabetes and Its Complications Among US Latinos
- ClinicalTrials.gov ID
- NCT03830840
- Acronym / sponsor ID
- 2017 - 6004
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Type 2 diabetes, Cardio-metabolic disease, Latino/Hispanic, Especialista, Community health worker, Social determinants of health, LatinX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, including children and youth, and measuring the 5 determinants of human health: genetics, biology, behavior, psychology, and society/environment.
Detailed description
The vision of Mil Familias is to reduce the burden of cardio-metabolic disease among Latino families in Santa Barbara County and beyond. The aim is to establish an observational cohort of 1,000 Latino families, with at least one family member currently living with diabetes, in order to understand better the impact of the 5 determinants of human health (genetics, biology, behavior, psychology, and society/environment) in this population. Once the 1,000-family cohort is established, evidence-based intervention studies will be developed and implemented based on new knowledge, with collaborators from the healthcare, public policy, academic, pharmaceutical, medical device and technology industries. The strategy involves 4 coordinated and iterative components to achieve its mission:
- Especialistas: Trusted, bilingual community health workers specially-trained in diabetes education, clinical research methodologies, and care referral. The Especialistas will engage directly with participants to conduct research activities, answer questions, and when necessary, refer participants to appropriate, local community resources.
- Data: Facilitated by Especialistas, each individual participant will contribute information on up to 100 different variables relating to their genetics, biology, psychology, behavior and society/environment, thus creating a one-of-a-kind database and associated specimen biobank on Latino health and lifestyle ("Living Information Bank").
- Interventions: Based on the data, evidence-based, collaborative, culturally-relevant prevention and treatment strategies are planned to develop once the cohort of 1,000 families has been established.
- Allies: This community-based participatory research study requires engagement from key stakeholders from the Latino community, healthcare sectors, hospitals, payers, businesses, people with diabetes and philanthropists. Organizations and individuals support Mil Familias by contributing their resources, experiences, and skill-sets.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult Individuals with Type 2 diabetes | – | –Individuals ≥18 years of Hispanic/Latino heritage with an established diagnosis of type 2 diabetes |
| Adult Family member | – | –Adult family members, ≥18 years, of the individual with type 2 diabetes |
| Child family member with diabetes | – | –Child, ≥7 years but <18 years, family member with diabetes |
| Child family member without diabetes | – | –Child, ≥7 years but <18 years, family member without diabetes |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 1,200 families may be screened and enrolled with the prediction of 20% screen-fail or dropout and 1,000 families enrolled in the study. A "family" will be followed as one unit but is estimated to include on average 3 to 5 individuals based on the findings from the Operational Pilot. Up to 6,000 individuals may be enrolled in this study.
Key inclusion criteria (6 listed)
- Males or females ≥ 7 years of age at enrollment.
- Self-reported Latino heritage.
- Co-resides with immediate family member (as defined above) OR self with established diagnosis of Type 2 Diabetes for at least one year prior to enrollment date.
- Signed and dated written informed consent by the date of enrollment.
- Based on the research staff's judgment, subject or subject's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion.
Key exclusion criteria (5 listed)
- Life expectancy < 6 months.
- Any active clinically significant physical or mental disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
- Language barriers precluding comprehension of study activities and informed consent.
- Participation in other trials involving medication or device within 1 month prior to enrollment.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot.
Time frame: 3 years
The Mil Familias Cohort Establishment will expand upon the Mil Familias Operational Pilot cohort and infrastructure to collect and store the up to 100 proposed variables across the 5 determinants of human health to support long-term Mil Familias implementation. The variables pertaining to each participant will be collected and stored at the initial visit and then annually for up to 3 years. Socio-demographic characteristics of the cohort will be described at enrollment by type 2 diabetes status, including age, gender, self-identified race/ethnicity, number of people in household, education, insurance, income, occupation, HbA1c, and country of birth.
57 secondary outcomes
Socio-demographics assessed by questionnaire.
Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire
Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions
Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
Total daily tortilla consumption
Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
Daily sugary drink consumption
Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
Number of times per week eating meals prepared away from home
Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years
Laboratory blood draw for evaluation of C-Peptide related to diabetes
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of C-Reactive protein related to diabetes
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Complete Blood Count
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Comprehensive Metabolic Panel
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of HbA1c related to diabetes
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of lipids
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of Insulin
Time frame: Laboratory encounter and annually up to 3 years
Laboratory blood draw for evaluation of thyroid function
Time frame: Laboratory encounter and annually up to 3 years
Microalbumin measured in a urine sample
Time frame: Laboratory encounter and annually up to 3 years
Creatinine measured in a urine sample
Time frame: Laboratory encounter and annually up to 3 years
Microalbumin/creatinine ratio measured in a urine sample
Time frame: Laboratory encounter and annually up to 3 years
Cheek cells and saliva for genomic analysis
Time frame: Laboratory encounter and annually up to 3 years
Stool samples for microbiome analysis
Time frame: Laboratory encounter and annually up to 3 years
Height measured by Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Weight measured by Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Waist circumference measured by Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Blood pressure measured by Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Temperature measured by Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Heart rate measured by Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Foot examination evaluated by Questions and Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Neuropathy Questions during Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Retinopathy questions during Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Dental exam Questions during Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Eye exam Questions during Physical exam
Time frame: Physical exam encounter and annually up to 3 years
Medical history, family medical history, and medication status and history assessed by interview
Time frame: Physical exam encounter and annually up to 3 years
Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview
Time frame: Physical exam encounter and annually up to 3 years
Determination of diabetes related foot disease
Time frame: Questionnaires encounter and annually up to 3 years
Acculturation measured by the Brief Acculturation Scale for Hispanics (BASH)
Time frame: Questionnaire encounter and annually up to 3 years
Quality of life measured by the Short Form Health Survey (SF-12)
Time frame: Questionnaires encounter and annually up to 3 years
Depression measured by the Patient Health Questionnaire-9
Time frame: Questionnaires encounter and annually up to 3 years
Perceived Ethnic Discrimination measured by the Brief Perceived Ethnic Discrimination Questionnaire - Community version (PEDQ-CV)
Time frame: Questionnaires encounter and annually up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Derived from this study: PubMed 35771029Kerr D, Abbasi M, Bevier W, Glantz N, Larez A, Sabharwal A. Patterns of Timing and Intensity of Physical Activity and HbA1c Levels in Hispanic/Latino Adults With or at Risk of Type 2 Diabetes. J Diabetes Sci Technol. 2024 Jan;18(1):106-112. doi: 10.1177/19322968221105531. Epub 2022 Jun 30.
- Derived from this study: PubMed 31906923Morales J, Glantz N, Larez A, Bevier W, Conneely M, Fan L, Reed B, Alatorre C, Paczkowski R, Ahmed T, Mackenzie A, Duncan I, Kerr D. Understanding the impact of five major determinants of health (genetics, biology, behavior, psychology, society/environment) on type 2 diabetes in U.S. Hispanic/Latino families: Mil Familias - a cohort study. BMC Endocr Disord. 2020 Jan 6;20(1):4. doi: 10.1186/s12902-019-0483-z.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in publications.
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, MBChB DM FRCP principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes Mellitus and Cardiovascular Diseases, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830840, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.