Northern Manhattan Study of Metabolism and Mind (NOMEM)
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|ClinicalTrials.gov Identifier: NCT02470260|
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : June 5, 2019
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|
|Diabetes Pre-diabetes Cognition - Other Depressive Symptoms Metabolic Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Northern Manhattan Study of Metabolism and Mind|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Defined by clinical history or HbA1c criteria (HbA1c greater of equal to 6.5%)
Defined by HbA1c criteria (5.7 to 6.4%)
Normal glucose tolerance
Defined by HbA1c criteria (< 5.7%)
- Cognition [ 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.
- Transitions in diabetes status [ 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%).
- Metabolic syndrome [ 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.
- Depressive symptoms [ Time Frame: 6 years ]assessed with the PHQ9 and the PROMIS depression scale
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470260
|Contact: Rafi Cabralemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator: Jose A Luchsinger, MD|
|Principal Investigator:||Jose A Luchsinger, MD||Columbia University|