Assessing Inherited Markers of Metabolic Syndrome in the Young (AIMM Young)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Children's Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Howard University
University of Massachusetts, Worcester
East Carolina University
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00966407
First received: August 24, 2009
Last updated: March 10, 2011
Last verified: March 2011

August 24, 2009
March 10, 2011
February 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00966407 on ClinicalTrials.gov Archive Site
Perception of physical fitness; Relationship between physiological measures and genotype variation [ Time Frame: Cross-sectional, one-time ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessing Inherited Markers of Metabolic Syndrome in the Young
Assessing Inherited Markers of Metabolic Syndrome in the Young

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
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)

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.

  • Metabolic Syndrome
  • Diabetes Mellitus, Type 2
  • Obesity
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 35 Years
Yes
Contact: Sembel Debessai 202-476-4718 sdebessai@cnmcresearch.org
Contact: Gina Many, M.S. gmany@cnmcresearch.org
United States
 
NCT00966407
CNMC IRB#3842, 2P20MD000198-06
No
Eric P. Hoffman, Children's National Medical Center
Children's Research Institute
  • National Institutes of Health (NIH)
  • Howard University
  • University of Massachusetts, Worcester
  • East Carolina University
Principal Investigator: Eric P Hoffman, Ph.D Children's Research Institute
Children's Research Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP