NOMEM: Northern Manhattan Study of Metabolism and Mind

Sponsor

Columbia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02470260

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

1,000

Enrollment

Location

173

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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:

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Pre-diabetes Cognition - Other Depressive Symptoms Metabolic Syndrome

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Northern Manhattan Study of Metabolism and Mind

Actual Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Diabetes Defined by clinical history or HbA1c criteria (HbA1c greater of equal to 6.5%)
Pre-diabetes Defined by HbA1c criteria (5.7 to 6.4%)
Normal glucose tolerance Defined by HbA1c criteria (< 5.7%)

Outcome Measures

Primary Outcome Measures

Cognition [6 years]
cognitive change over at least 3 follow-ups measured with the Selective Reminding Test, Color trails test, and Animal fluency tests.

Secondary Outcome Measures

Transitions in diabetes status [6 years]
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%).
Metabolic syndrome [6 years]
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.
Depressive symptoms [6 years]
assessed with the PHQ9 and the PROMIS depression scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.