AzTrials
AzTrials

DiabetesNOMEMNCT02470260

Northern Manhattan Study of Metabolism and Mind

An observational study of Diabetes and Pre-diabetes, run by Columbia University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Pre-diabetes, type 2 diabetes, and their related conditions, adiposity and insulin resistance, are more prevalent in minorities Northern Manhattan compared to the general population of the United States. Read more about this study

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Pre-diabetes, Cognition - Other
How many people
1,000 participants
Where
1 siteUnited States
Study dates
Jan 2012to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 50 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Middle aged Hispanics from Northern Manhattan, New York City

Who may be able to join

  • Self identified Hispanic (any Hispanic subgroup)
  • Man or woman.
  • Between the ages of 50 and 64 years at baseline

Who cannot join

  • History of cancer other than non-melanoma skin cancer
  • The expectation of moving out for the country permanently before during the study period
  • Presence of a clinical diagnosis of dementia, which we anticipate will be unlikely in this age group.
  • Visual, hearing, or physical impairment that precludes active participation in the study and inability to complete study questionnaires.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University Irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Pre-diabetes, type 2 diabetes, and their related conditions, adiposity and insulin resistance, are more prevalent in minorities Northern Manhattan compared to the general population of the United States. Despite knowledge of the main biologic determinants of these conditions (high caloric intake and sedentarism) the prevalence of these conditions continue to increase. In addition, these conditions can cause mental health problems including increased depressive symptoms and cognitive impairment. Thus, the investigators decided to conduct a community based study of middle aged Hispanic men and women aged 50 to 64 years at baseline in order to:

  1. Document the prevalence and incidence, of pre-diabetes, diabetes, overweight, obesity, and associated conditions (e.g. dyslipidemia, hypertension).
  2. Study how social determinants of health (SDOH) affect these conditions.
  3. Study the consequences of these conditions on aging and mental health outcomes, including cognitive impairment.
Read the detailed description

DESIGN OVERVIEW: the Northern Manhattan Study of Metabolism and Mind (NOMEM) is a longitudinal cohort study of middle aged Hispanics. Recruitment of the initial cohort of 600 participants was completed between January of 2012 and December of 2013. Our total target sample size is 1000 participants. Participants are followed every 2 years. Participants are self-identified Hispanic men and women aged 50 to 65 years. The sampling frame is the community of Northern Manhattan in New York City.

Participants undergo phlebotomy, measurement of vital signs and anthropometric measures, interviews of medical history, cognitive assessments, and interviews of social determinants of health and mental and physical conditions. Assessments take between 2 and 3 hours.

VARIABLES:

  • Glycemia and diabetes status: glycemia is measured with HbA1c. Diabetes is defined by clinical history or by HbA1c ≥ 6.5%, following 2010 ADA criteria. Pre-diabetes is determined following ADA 2010 criteria (HbA1c 5.7 to 6.4%).
  • APOE genotyping: The 3 APOE alleles will be genotyped, ε2, ε3, and ε4.
  • Body Mass Index (BMI). Standing height is measured using a stadiometer calibrated in cm. Body weight is measured using a balance beam scale calibrated in kg. With the participant standing, measurements are taken to the nearest 0.1 kg of weight with a balance scale and height without shoes to nearest 0.5 cm, to calculate BMI (weight/height2). (use: covariate, ancillary studies).
  • Demographic variables: We collect date of birth, sex, years and education, racial group, and country of origin (following the 2010 census format for Hispanics) (use: covariates).
  • Depression: We measure depression and depressive symptoms using the PHQ9 and the PROMIS depression scale.
  • High sensitivity CRP: Measured using ELISA (Diagnostic systems laboratories, INC, Webster, Texas). The assay sensitivity is 1.6 ng/ml, the inter-assay CV is 11.7%, and the intra-assay CV is 4.6%. This assay can be conducted in serum or plasma.
  • Lipids: total cholesterol (TC), HDL. TC and HDL are measured using enzymatic colorimetric methods (Vitros; Johnson \& Johnson, New Brunswick, NJ).
  • Medical history.This includes vascular disease, cancer, and smoking
  • Medications: We will record medications, vitamins, and over the counter products (use: covariate, ancillary studies).
  • Resting blood pressure (BP): BP will be measured using an automated oscillometric device; 3 measurements are obtained at 1-minute intervals in a seated position after 5 minutes of rest. The average of the 2nd and 3rd measurements will be recorded as the BP.
  • Waist and hip circumference: Waist circumference is measured at the level of the umbilicus. Hip circumference is measured at the level of maximal protrusion of the gluteal muscles. Waist-hip ratio is calculated as the ratio of waist circumference to hip circumference.
  • Cognitive battery:
  • WAIS-R Similarities. This Wechsler Adult Intelligence Scale-Revised subtest has good norms and is a standard portion of a dementia evaluation. The items have been translated into Spanish and a scoring guide has been developed. Age-Scaled scores will be used. [Max. Score=19; Time=5 min] Non-Verbal Similarities. The Identities and Oddities subtest of the Mattis Dementia Rating Scale is used to assess nonverbal abstract reasoning. [Max. Score=16; Time=2 min]
  • Color Trails Test Color Trails 1 is a test of sustained visual attention, psychomotor speed, and simple sequencing and involves connecting circles containing the numbers 1 through 25 in order as quickly as possible. Color Trails 2 also involves connecting circles containing the numbers 1 through 25 in order as quickly as possible, but the examinee must shift between pink and yellow colored circles. Like Part 1, Color Trails 2 assesses visual attention and psychomotor speed but also requires a higher level of executive functioning skills.
  • Verbal Fluency: Controlled Word Association Test. The patient is given 1 min to name as many words beginning with a particular letter as s/he can. Norms and frequency counts exist for this test in Spanish as well as English. Three categories, Animals, Food, and Clothing are administered to assess category naming. [Time=7 min]
  • The Selective Reminding Test (SRT) is a standard tool in the assessment of verbal memory and dementia and has been used as a sensitive longitudinal measure of changes in memory function. The SRTwas translated into Spanish using words of similar frequency to those in the standard test versions. Subjects are given 6 trials to learn a list of 12 unrelated words. After each attempt at recalling the list, the subject is reminded only of the words that were not recalled and then must attempt to recall the entire list. To assess short-term memory, 2 measures are used: total recall (max. score=72) and retrieval from long-term storage (max. score=72). To assess long-term recall, delayed recall is assessed 15 minutes after completing the SRT (max. score=12); recognition of words not recalled is then tested using multiple choice arrays (max. score=12). [Time (not including 15 min. delay interval, during which other tests are administered) =15 min].
  • The orientation items from the modified Mini-Mental State Examination are used to assess orientation to time and place. These items are sensitive to dementing changes in our normative samples. [Max. Score=10; Time to administer=2 min]
  • Social Determinants of Health:
  • Individual SES: MacArthur Network on SES and Health Measures Household income/number of people supported, wealth, debt, how long one could live at current lifestyle if current sources of income ceased
  • Perceived Social Status: MacArthur Ladder; Perceived relative standing in the US
  • Migration: Age at migration Years of life in US
  • Everyday Discrimination* Everyday Discrimination; 10 items; Daily discriminatory hassles
  • Major Discrimination* Modified Experiences of Discrimination Scale: 12 items; Frequency measure of total lifetime occurrences; 0=Never to 5=Four or More Times
  • Coping with Discrimination-Psychosocial Experiences of Discrimination Scale; 3 coping styles-0=Passive (accept/quiet); 1=Moderate (quiet); 2=Engaged (do something/talk to others)
  • Coping with Discrimination-Health Behavior Modified Experiences of Discrimination Scale 4 behaviors-Exercising, eating sweets/fatty foods, drinking alcohol, smoking cigarettes 0=Never; 3=most of the time
  • Coping with Stress-Psychosocial Based on Experiences of Discrimination Scale 3 coping styles-0=Passive (accept/quiet); 1=Moderate (quiet); 2=Engaged (do something/talk to others)
  • Coping with Stress-Health Behavior Modified Experiences of Discrimination Scale 4 behaviors-Exercising, eating sweets/fatty foods, drinking alcohol, smoking cigarettes; 0=Never; 3=most of the time
  • Racial/Ethnic Socialization Racial/Ethnic Socialization Scale 15 items; 0=Never, 1=Almost Never; 2=Sometimes; 3=Often; 4=Very Often
  • Ethnic Identity Multi-Ethnic Identity Measure 12 items from Affirmation and Belonging and Ethnic Identity Search subscales
  • Acculturation Bidimensional Acculturation Scale Average of 12 items in each domain (Hispanic, Non-Hispanic)
  • Alcohol Use Alcohol Use Disorders Identification Test 10 items; Items scored 0-4
  • Smoking From COHD battery Cigarettes smoked daily
  • Diet Behavioral Risk Factor Surveillance System 6 items; 1=More than Once a Day; 5=Less than Once a Week
  • Physical Activity IPAQ Summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities to estimate MET minutes/week
  • Barriers to Exercise* Benefits and Barriers to Exercise71 9 items; 0=Never; 5=Very Often
  • John Henryism John Henryism Active Coping Scale 12 items; 1=Completely True; 5=Completely False
  • Social Support Social Support Questionnaire Count # of people for odd items. Add totals (Max=54). Divide by 6 for per item SSQ Number Score. Add total Satisfaction score for 6 even numbered items
  • Neighborhood Resources Census-derived neighborhood deprivation % living or below poverty line
Keywords
Diabetes, Pre-diabetes, Cognition, Depressive symptoms
Medical subject headings
Diabetes Mellitus, Glucose Intolerance, Depression, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02470260
Study groupRoleWhat they receive
DiabetesDefined by clinical history or HbA1c criteria (HbA1c greater of equal to 6.5%)
Pre-diabetesDefined by HbA1c criteria (5.7 to 6.4%)
Normal glucose toleranceDefined by HbA1c criteria (< 5.7%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognition

    cognitive change over at least 3 follow-ups measured with the Selective Reminding Test, Color trails test, and Animal fluency tests.

    Measured: 6 years

Secondary outcomes (3)
  1. Transitions in diabetes status

    Transition from a diabetes state (normal glucose tolerance, pre-diabetes, diabetes) to another state (normal glucose tolerance, pre-diabetes,diabetes).

    HbA1 is used to ascertain Normal glucose tolerance (HbA1c < 6.7%) and pre-diabetes (HbA1c between 6.7 and 6.49%).

    Measured: 6 years

  2. Metabolic syndrome

    The components of the metabolic syndrome are:hyperglycemia (pre diabetes or diabetes), central obesity (determined with waist circumference, low HDL, hypertension, and inflammation (hsCRP > 3); the metabolic syndrome is present when 3 or more of the components are present.

    Measured: 6 years

  3. Depressive symptoms

    assessed with the PHQ9 and the PROMIS depression scale

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study startJan 2012
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02470260
Sponsor's protocol ID
AAAQ2950
Other IDs
P60MD000206, R01AG050440
Acronym
NOMEM
Status last verified
May 2025
First submitted
8 Jun 2015
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Pre-diabetes, run by Columbia University 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Cognition (time frame: 6 years). 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 7 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in