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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 : September 15, 2015
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
José A. Luchsinger, Columbia University

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. 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.

Condition or disease
Diabetes Pre-diabetes Cognition - Other Depressive Symptoms Metabolic Syndrome

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Group/Cohort
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%)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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%).


  2. 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.

  3. Depressive symptoms [ Time Frame: 6 years ]
    assessed with the PHQ9 and the PROMIS depression scale


Biospecimen Retention:   Samples With DNA
whole blood for DNA extraction, plasma, sera


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Middle aged Hispanics from Northern Manhattan, New York City
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470260


Contacts
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Contact: Rafi Cabral 646-5841166 rc2415@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Jose A Luchsinger, MD         
Sponsors and Collaborators
Columbia University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Jose A Luchsinger, MD Columbia University

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Responsible Party: José A. Luchsinger, Associate Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT02470260     History of Changes
Other Study ID Numbers: AAAI5156
P60MD000206 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by José A. Luchsinger, Columbia University:
Diabetes
Pre-diabetes
Cognition
Depressive symptoms

Additional relevant MeSH terms:
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Metabolic Syndrome
Diabetes Mellitus
Depression
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Behavioral Symptoms
Hyperglycemia