Columbia University Irving Medical Center
New York, 10032, United States
NCT Number: NCT02470260
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.
This study is active but is not currently recruiting participants.
50 year–64 year
All sexes
Observational
New York, 10032, United States
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:
12 items; Frequency measure of total lifetime occurrences; 0=Never to 5=Four or More Times
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 years
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
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
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
assessed with the PHQ9 and the PROMIS depression scale
Columbia University
Other
Acronym: NOMEM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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