An observational study in Diabetes, Pre-diabetes and Cognition - Other, sponsored by Columbia University. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Columbia University · Observational
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:
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:
Cognitive battery:
Social Determinants of Health:
Major Discrimination* Modified Experiences of Discrimination Scale:
12 items; Frequency measure of total lifetime occurrences; 0=Never to 5=Four or More Times
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
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Middle aged Hispanics from Northern Manhattan, New York City
Exclusion Criteria:
History of cancer other than non-melanoma skin cancer
Defined by clinical history or HbA1c criteria (HbA1c greater of equal to 6.5%)
Defined by HbA1c criteria (5.7 to 6.4%)
Defined by HbA1c criteria (\< 5.7%)
Cognition
cognitive change over at least 3 follow-ups measured with the Selective Reminding Test, Color trails test, and Animal fluency tests.
Time frame: 6 years
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%).
Time frame: 6 years
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.
Time frame: 6 years
Depressive symptoms
assessed with the PHQ9 and the PROMIS depression scale
Time frame: 6 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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