Assessing Inherited Markers of Metabolic Syndrome in the Young (AIMM Young)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 24, 2009 | ||||||||
| Last Updated Date | March 10, 2011 | ||||||||
| Start Date ICMJE | February 2007 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Genotype for specific genes related to obesity, metabolic syndrome, and/or type 2 diabestes; 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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00966407 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Perception of physical fitness; Relationship between physiological measures and genotype variation [ Time Frame: Cross-sectional, one-time ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessing Inherited Markers of Metabolic Syndrome in the Young | ||||||||
| Official Title ICMJE | Assessing Inherited Markers of Metabolic Syndrome in the Young | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood samples are obtained for DNA extraction and measuring various biomarkers (including fasting glucose, insulin, lipid profile, and hemoglobin A1c) |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1500 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00966407 | ||||||||
| Other Study ID Numbers ICMJE | CNMC IRB#3842, 2P20MD000198-06 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Eric P. Hoffman, Children's National Medical Center | ||||||||
| Study Sponsor ICMJE | Children's Research Institute | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Children's Research Institute | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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