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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966407
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : February 9, 2017
National Institute on Minority Health and Health Disparities (NIMHD)
Howard University
University of Massachusetts, Worcester
East Carolina University
Information provided by (Responsible Party):
Eric Hoffman, Children's Research Institute

Brief Summary:

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.

Condition or disease
Metabolic Syndrome Diabetes Mellitus, Type 2 Obesity

Study Type : Observational
Actual Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing Inherited Markers of Metabolic Syndrome in the Young
Actual Study Start Date : February 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Perception of physical fitness; Relationship between physiological measures and genotype variation [ Time Frame: Cross-sectional, one-time ]

Biospecimen Retention:   Samples With DNA
Blood samples are obtained for DNA extraction and measuring various biomarkers (including fasting glucose, insulin, lipid profile, and hemoglobin A1c)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

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 identifier (NCT number): NCT00966407

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Eric Hoffman
National Institute on Minority Health and Health Disparities (NIMHD)
Howard University
University of Massachusetts, Worcester
East Carolina University
Principal Investigator: Eric P Hoffman, Ph.D Children's Research Institute

Publications of Results:
Responsible Party: Eric Hoffman, MD, Children's Research Institute Identifier: NCT00966407     History of Changes
Other Study ID Numbers: CNMC IRB#3842
2P20MD000198-06 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Eric Hoffman, Children's Research Institute:
Metabolic Syndrome
Genetic risk markers
Single Nucleotide Polymorphisms
Young adults
Fitness testing

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Diabetes Mellitus, Type 2
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance