Assessing Inherited Markers of Metabolic Syndrome in the Young
This trial has been completed.
|Conditions||metabolic syndrome, diabetes mellitus, type 2, obesity|
|Collaborator||National Institute on Minority Health and Health Disparities (NIMHD)|
|Start date||February 2007|
|End date||December 2015|
|Trial size||700 participants|
|Trial identifier||NCT00966407, 2P20MD000198-06, CNMC IRB#3842|
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.
College-age (18-35 years) participants recruited from Howard University, East Carolina University, and University of Massachusetts, Amherst, University of Calgary, Winston-Salem University
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
Perception of physical fitness; Relationship between physiological measures and genotype variation
time frame: Cross-sectional, one-time
All 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.
|Official title||Assessing Inherited Markers of Metabolic Syndrome in the Young|
|Principal investigator||Eric P Hoffman, Ph.D|
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