Assessing Inherited Markers of Metabolic Syndrome in the Young
AIMMY
2 other identifiers
observational
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 9, 2017
February 1, 2017
8.8 years
August 24, 2009
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Cross-sectional, one-time measure
Secondary Outcomes (1)
Perception of physical fitness; Relationship between physiological measures and genotype variation
Cross-sectional, one-time
Study Arms (1)
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 Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eric Hoffmanlead
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
- Howard Universitycollaborator
- University of Massachusetts, Worcestercollaborator
- East Carolina Universitycollaborator
Study Sites (1)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Related Publications (4)
Deschamps CL, Connors KE, Klein MS, Johnsen VL, Shearer J, Vogel HJ, Devaney JM, Gordish-Dressman H, Many GM, Barfield W, Hoffman EP, Kraus WE, Hittel DS. The ACTN3 R577X Polymorphism Is Associated with Cardiometabolic Fitness in Healthy Young Adults. PLoS One. 2015 Jun 24;10(6):e0130644. doi: 10.1371/journal.pone.0130644. eCollection 2015.
PMID: 26107372RESULTMany GM, Lutsch A, Connors KE, Shearer J, Brown HC, Ash G, Pescatello LS, Gordish-Dressman H, Barfield W, Dubis G, Houmard JA, Hoffman EP, Hittel DS. Examination of Lifestyle Behaviors and Cardiometabolic Risk Factors in University Students Enrolled in Kinesiology Degree Programs. J Strength Cond Res. 2016 Apr;30(4):1137-46. doi: 10.1519/JSC.0000000000000871.
PMID: 25647655RESULTKarlos A, Shearer J, Gnatiuk E, Onyewu C, Many G, Hoffman EP, Hittel DS. Effect of the SORT1 low-density lipoprotein cholesterol locus is sex-specific in a fit, Canadian young-adult population. Appl Physiol Nutr Metab. 2013 Feb;38(2):188-93. doi: 10.1139/apnm-2012-0231. Epub 2012 Nov 1.
PMID: 23438231RESULTArnold TJ, Schweitzer A, Hoffman HJ, Onyewu C, Hurtado ME, Hoffman EP, Klein CJ. Neck and waist circumference biomarkers of cardiovascular risk in a cohort of predominantly African-American college students: a preliminary study. J Acad Nutr Diet. 2014 Jan;114(1):107-16. doi: 10.1016/j.jand.2013.07.005. Epub 2013 Sep 16.
PMID: 24051106RESULT
Biospecimen
Blood samples are obtained for DNA extraction and measuring various biomarkers (including fasting glucose, insulin, lipid profile, and hemoglobin A1c)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric P Hoffman, Ph.D
Children's National Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 26, 2009
Study Start
February 1, 2007
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
February 9, 2017
Record last verified: 2017-02