Overview

This trial is active, not recruiting.

Conditions metabolic syndrome, diabetes mellitus, type 2, obesity
Sponsor Eric Hoffman
Collaborator National Institutes of Health (NIH)
Start date February 2007
End date December 2015
Trial size 1500 participants
Trial identifier NCT00966407, 2P20MD000198-06, CNMC IRB#3842

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
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 Outcomes

Measure
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

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

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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.

Additional Information

Official title Assessing Inherited Markers of Metabolic Syndrome in the Young
Principal investigator Eric P Hoffman, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Children's Research Institute.