Assessing Inherited Markers of Metabolic Syndrome in the Young (AIMM Young)
Recruitment status was Recruiting
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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.
| Condition |
|---|
|
Metabolic Syndrome Diabetes Mellitus, Type 2 Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Assessing Inherited Markers of Metabolic Syndrome in the Young |
- 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 ] [ Designated as safety issue: No ]
- Perception of physical fitness; Relationship between physiological measures and genotype variation [ Time Frame: Cross-sectional, one-time ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples are obtained for DNA extraction and measuring various biomarkers (including fasting glucose, insulin, lipid profile, and hemoglobin A1c)
| Estimated Enrollment: | 1500 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Healthy Young Adults
College-age (18-35 years) participants recruited from Howard University, East Carolina University, and University of Massachusetts, Amherst, University of Calgary, Winston-Salem University
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
The population from which cohorts will be selected include students, residents, staff, and/or faculty who are present on Howard University, East Carolina University, and/or University of Massachusetts, Amherst campuses and surrounding areas.
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.
Contacts and Locations| Contact: Sembel Debessai | 202-476-4718 | sdebessai@cnmcresearch.org |
| Contact: Gina Many, M.S. | gmany@cnmcresearch.org |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Sembel Debessai 202-476-4718 sdebessai@cnmcresearch.org | |
| Principal Investigator: Eric P Hoffman, PhD | |
| Principal Investigator: | Eric P Hoffman, Ph.D | Children's Research Institute |
More Information
No publications provided
| Responsible Party: | Eric P. Hoffman, Children's National Medical Center |
| ClinicalTrials.gov Identifier: | NCT00966407 History of Changes |
| Other Study ID Numbers: | CNMC IRB#3842, 2P20MD000198-06 |
| Study First Received: | August 24, 2009 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Research Institute:
|
Metabolic Syndrome Obesity Genetic risk markers |
Single Nucleotide Polymorphisms Young adults Fitness testing |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on May 22, 2013