Assessing Inherited Markers of Metabolic Syndrome in the Young

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

Perception of physical fitness; Relationship between physiological measures and genotype variation

Time frame: Cross-sectional, one-time

Sponsors and collaborators

Lead sponsor

Eric Hoffman

Other

Collaborators

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

Registry information

Acronym: AIMMY

Important dates

Study start: 2007
Primary completion: 2015
Study completion: 2016
First posted: Aug 26, 2009
Registry last updated: Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

Completed