View Clinical Trial (Medical Research Study)
Assessing Inherited Markers of Metabolic Syndrome in the Young
| City: |
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Washington |
| State: |
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District of Columbia |
| Zip Code: |
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20010 |
| Conditions: |
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Metabolic Syndrome - Diabetes Mellitus, Type 2 - Obesity |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT00966407 |
| Primary Contact: |
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Principal Investigator Eric P Hoffman, Ph.D Children's Research Institute
Sembel Debessai Phone: 202-476-4718 Email: sdebessai@cnmcresearch.org
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| Backup Contact: |
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Email: gmany@cnmcresearch.org Gina Many, M.S.
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| Location Contact: |
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Washington, District of Columbia 20010 United States
Sembel Debessai Phone: 202-476-4718 Email: sdebessai@cnmcresearch.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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