Northern Manhattan Study of Metabolism and Mind

NCT02470260 | Active Not Recruiting

• 3 other identifiers: AAAQ2950P60MD000206R01AG050440
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Diabetes; Pre-diabetes; Cognition - Other; Depressive Symptoms; Metabolic Syndrome

Keywords

Diabetes; Pre-diabetes; Cognition; Depressive symptoms

Outcome Measures

Primary Outcomes (1)

• Cognition

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

  6 years

Secondary Outcomes (3)

• Transitions in diabetes status

  6 years

• Metabolic syndrome

  6 years

• Depressive symptoms

  6 years

Study Arms (3)

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%)

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Middle aged Hispanics from Northern Manhattan, New York City

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood for DNA extraction, plasma, sera

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Depression; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Behavioral Symptoms; Behavior; Insulin Resistance; Hyperinsulinism

Study Officials

• Jose A. Luchsinger, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 12, 2015
• Study Start: January 1, 2012
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (1)