Assessing Inherited Markers of Metabolic Syndrome in the Young (AIMMY)

February 8, 2017 updated by: Eric Hoffman

The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and colleges/universities nationwide--currently including Howard University (HU), East Carolina University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a variety of baseline measures (such as serum biomarkers related to metabolic syndrome, anthropometrics, muscle strength, and fitness testing) along with genetic information from healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype associations that may predispose individuals to developing metabolic syndrome, type 2 diabetes, and/or related diseases such as obesity.

We hypothesized that certain genetic variations will be protective against metabolic syndrome, while others will show a strong correlation with specific components of metabolic syndrome disease. We expect that the study of "pre-symptomatic," young individuals will facilitate the identification of genetic risk loci for metabolic syndrome and type 2 diabetes. Younger populations typically have less confounding variables, and this facilitates normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young subjects can provide more robust longitudinal data, and be recruited into subsequent interventions to reverse the trend towards metabolic syndrome, rather than the more difficult task of reversing type 2 diabetes in older populations. The data collected will be stratified according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how these factors influence disease risk.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population from which cohorts will be selected include students, residents, staff, and/or faculty who are present on Howard University, East Carolina University, and/or University of Massachusetts, Amherst campuses and surrounding areas.

Description

Inclusion Criteria:

  • between the ages of 18 and 35 years
  • post-puberty
  • willing and able to provide informed consent
  • stable medical and psychosocial status providing a high likelihood of follow-up and compliance with study protocol
  • all ethnic backgrounds will be included in this study.

Exclusion Criteria:

  • evidence of clinically relevant systemic disease associated with disorders of glucose metabolism
  • chronic use of glucocorticoid or appetite suppressants
  • concomitant use of drugs known to alter glucose metabolism (i.e., metformin, thiazolidinediones, sulfonylurea receptor agonists and inhibitors of alpha-glucoside hydrolase) or other medications known to alter blood levels being tested in this study
  • inability to provide the requested fasting blood sample
  • pregnancy
  • menopause
  • alcohol dependency (as determined by CAGE screening questionnaire); (8) inability to provide informed consent
  • previous diagnosis or treatment for any hematologic-oncologic disorder
  • history or current treatment for an eating disorder
  • current treatment for weight loss
  • history of bariatric surgery
  • history of neurosurgical procedure
  • participation in another clinical trial involving an investigational drug
  • history of psychiatric disorder, which in the opinion of the investigator would affect the conduct of the proposed trial
  • age younger than 18 or older than 35 at the time of recruitment
  • weight that exceeds the capacity of equipment used for weight measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Young Adults
College-age (18-35 years) participants recruited from Howard University, East Carolina University, and University of Massachusetts, Amherst, University of Calgary, Winston-Salem University

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genotype for specific genes related to obesity, metabolic syndrome, and/or type 2 diabetes; Fasting serum biomarkers; Hand grip strength, muscle strength of upper and lower extremities; Fitness measurements; Body composition measures
Time Frame: Cross-sectional, one-time measure
Cross-sectional, one-time measure

Secondary Outcome Measures

Outcome Measure
Time Frame
Perception of physical fitness; Relationship between physiological measures and genotype variation
Time Frame: Cross-sectional, one-time
Cross-sectional, one-time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eric Hoffman

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
University of Massachusetts, Worcester
East Carolina University
Howard University

Investigators

  • Principal Investigator: Eric P Hoffman, Ph.D, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2007

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNMC IRB#3842
  • 2P20MD000198-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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