Gestational DiabetesNCT03301519
Genetics of Beta Cell Failure in Mexican Americans
An observational study of Gestational Diabetes and Diabetes Type 2, run by University of Southern California.
Trial summary
This is a family based genotype-phenotype study designed to assess genetic and environmental influences on obesity, insulin resistance and beta cell function in the context of gestational diabetes. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Gestational Diabetes, Diabetes Type 2, Insulin Resistance
- How many people
- 1,250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2001to 31 May 2013
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: See Inclusion and Exclusion Criteria
Who may be able to join
- Probands with Prior Gestational Diabetes Mellitus ("GDM PROBANDS")
- Mexican American (parents and at least 3/4 four grandparents
- age >18 years
- GDM in singleton pregnancy in prior 5 years
- impaired glucose levels or sum of five OGTT glucose values >625 mg/dl on 75 gram oral glucose tolerance test
- Fasting plasma glucose <126 mg/dl
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- At least two adult siblings of cousin not known to have diabetes and available for phenotyping; .
- Siblings and Cousins of GDM Probands
- Full sibling or first cousin of GDM proband
- Age >18 yrs
- Fasting plasma glucose <126 mg/dl.
- Parents, Uncles and Aunts of GDM Probands
- Full blooded parent, uncle or aunt of GDM proband
- Control Proband
- Mexican American as defined for GDM probands
- One glucose challenge test result <120 mg/dl at >24 weeks gestation
- No diabetes in first degree relative
- Frequency matched to GDM probands by distributions of age, BMI and parity.
- Spouse of GDM or Control Proband
- Spouse of GDM proband
- Age >18
- At least one child with proband able to provide DNA
- Child of Proband
- Child of GDM or control proband and spouse who provided DNA
Who cannot join
- PROBANDS (GDM OR CONTROL):
- Chronic medical illness or medication known to alter glucose/insulin metabolism
- Current pregnancy or breastfeeding
- Ilicit drug or alcohol abuse,
- Inability or unwillingness to give informed consent.
- SIBLINGS AND COUSINS OF PROBANDS:
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- Chronic medical illness or medication known to affect glucose/insulin metabolism
- Current pregnancy or breastfeeding,
- Ilicit drug or alcohol abuse
- Inability or unwillingness to give informed consent.
- PARENTS OF PROBANDS
- Inability or unwillingness to give informed consent.
- SPOUSE OF GDM or CONTROL PROBAND
- Inability or unwillingness to give informed consent.
- CHILD OF GDM or CONTROL PROBAND
- Lack of parent consent or child assent.
About this study
This is a family based genotype-phenotype study designed to assess genetic and environmental influences on obesity, insulin resistance and beta cell function in the context of gestational diabetes.
Read the detailed description
Mexican American women with prior gestational diabetes and their first degree relatives and Mexican American women with prior normal glucose tolerance in pregnancy are studied with detailed phenotyping consisting of oral and intravenous glucose tolerance tests, body composition studies, diet and physical activity assessments, and circulating biomarkers potentially related to obesity, insulin resistance, pancreatic beta cell function, gestational diabetes and type 2 diabetes. Spouses of the gestational diabetic and control probands are studied with oral glucose tolerance tests. Offspring of the gestational and control probands have fasting glucose determinations. All participants provide DNA for genetics testing. A subset of the gestational diabetic probands and their first degree relatives return 3-5 years after baseline testing for repeat phenotyping.
- Conditions
- Gestational Diabetes, Diabetes Type 2, Insulin Resistance, Beta Cell Function, Genetics, Nutrition
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Insulin Resistance, Motor Activity, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic Beta Cell Compensation for Insulin Resistance
Disposition index from intravenous glucose tolerance test
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Secondary outcomes (8)
Insulin Senstivity
Si from computer modeled intravenous glucose tolerance test
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Acute Insulin Release
Incremental area under insulin curve during first 10 minutes intravenous glucose tolerance test
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Glucose tolerance
normal, impaired or diabetic glucose level determined using American Diabetes Associate criteria applied to glucose levels from a 2-hour, 75 gram oral glucose tolerance test
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Diabetes type 2
Fasting glucose >125 mg/dl and/or 2-hour glucose on 75 gram oral glucose tolerance test >199 mg/dl
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Dietary Intake
Measured by semi-quantitative Harvard Food Frequency Questionnaire
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Physical Activity
Measured by Multi-ethnic Cohort Physical Activity Questionnaire
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Body Fat
Percent body fat measured by dual photon X-ray absorptiometry
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Circulating adipokine levels
Fasting levels of approximately 20 adipocytokines
Measured: Single time point for primary cohort, repeated 4.5 years later in subset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Jul 2001
- Primary completion31 May 2013
- Study completion31 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Principal investigator, Thomas Buchanan, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301519
- Sponsor's protocol ID
- HS 013025
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Beta Cell Failure in Mexican Americans
- ClinicalTrials.gov ID
- NCT03301519
- Acronym / sponsor ID
- HS 013025
- Conditions
- Gestational Diabetes, Diabetes Type 2, Insulin Resistance, Beta Cell Function, Genetics, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- 1 Jul 2001 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 4 Oct 2017 (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.
This is a family based genotype-phenotype study designed to assess genetic and environmental influences on obesity, insulin resistance and beta cell function in the context of gestational diabetes.
Detailed description
Mexican American women with prior gestational diabetes and their first degree relatives and Mexican American women with prior normal glucose tolerance in pregnancy are studied with detailed phenotyping consisting of oral and intravenous glucose tolerance tests, body composition studies, diet and physical activity assessments, and circulating biomarkers potentially related to obesity, insulin resistance, pancreatic beta cell function, gestational diabetes and type 2 diabetes. Spouses of the gestational diabetic and control probands are studied with oral glucose tolerance tests. Offspring of the gestational and control probands have fasting glucose determinations. All participants provide DNA for genetics testing. A subset of the gestational diabetic probands and their first degree relatives return 3-5 years after baseline testing for repeat phenotyping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- See Inclusion and Exclusion Criteria
Key inclusion criteria (24 listed)
- Probands with Prior Gestational Diabetes Mellitus ("GDM PROBANDS")
- Siblings and Cousins of GDM Probands
- Parents, Uncles and Aunts of GDM Probands
- Control Proband
- Spouse of GDM or Control Proband
Key exclusion criteria (16 listed)
- PROBANDS (GDM OR CONTROL):
- SIBLINGS AND COUSINS OF PROBANDS:
- PARENTS OF PROBANDS
- SPOUSE OF GDM or CONTROL PROBAND
- CHILD OF GDM or CONTROL PROBAND
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
Pancreatic Beta Cell Compensation for Insulin Resistance
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Disposition index from intravenous glucose tolerance test
8 secondary outcomes
Insulin Senstivity
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Acute Insulin Release
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Glucose tolerance
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Diabetes type 2
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Dietary Intake
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Physical Activity
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Body Fat
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Circulating adipokine levels
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Diabetes Type 2, run by University of Southern California.
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 24 inclusion and 16 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Pancreatic Beta Cell Compensation for Insulin Resistance (time frame: Single time point for primary cohort, repeated 4.5 years later in subset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.