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

Eric Hoffman

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00966407

2P20MD000198-06 (U.S. NIH Grant/Contract)

CNMC IRB#3842

Details and patient eligibility

About

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.

Enrollment: 700 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

700 participants in 1 patient group

Healthy Young Adults

Description:

College-age (18-35 years) participants recruited from Howard University, East Carolina University, and University of Massachusetts, Amherst, University of Calgary, Winston-Salem University