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Assessing Inherited Markers of Metabolic Syndrome in the Young - NCT00966407-20010(Clinical Trial 307014)



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City:  Washington
State:  
DC
Zip Code: 20010
Conditions: Metabolic Syndrome - Diabetes Mellitus, Type 2 - Obesity
Purpose: 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 summary:
Criteria: 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 is available at: Children's National Medical Center
Washington, DC 20010
United States

Primary Contact:
Sembel Debessai
Email: sdebessai@cnmcresearch.org
Phone: 202-476-4718

Secondary Contact:
Sembel Debessai
Email: sdebessai@cnmcresearch.org
Phone: 202-476-4718
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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