Assessing Inherited Markers of Metabolic Syndrome in the Young

Obesity Clinical Trial

— AIMMY  

Official title:

Assessing Inherited Markers of Metabolic Syndrome in the Young

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966407
• Other study ID #: CNMC IRB#3842
• Secondary ID: 2P20MD000198-06
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: February 8, 2017
• Start date: February 2007
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Eric Hoffman	East Carolina University, Howard University, National Institute on Minority Health and Health Disparities (NIMHD), University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (4)

Arnold 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 — View Citation

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. PLo — View Citation

Karlos 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/ — View Citation

Many 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 Ki — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perception of physical fitness; Relationship between physiological measures and genotype variation		Cross-sectional, one-time