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
  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

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966407

Contacts
Contact: Sembel Debessai 202-476-4718 sdebessai@cnmcresearch.org
Contact: Gina Many, M.S. gmany@cnmcresearch.org

Locations
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         
Sponsors and Collaborators
Children's Research Institute
Howard University
University of Massachusetts, Worcester
East Carolina University
Investigators
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:
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on September 14, 2014