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Assessing Inherited Markers of Metabolic Syndrome in the Young

Assessing Inherited Markers of Metabolic Syndrome in the Young

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00966407
Acronym
AIMMY
Enrollment
700
Registered
2009-08-26
Start date
2007-02-28
Completion date
2016-12-31
Last updated
2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Metabolic Syndrome, Obesity

Keywords

Metabolic Syndrome, Obesity, Genetic risk markers, Single Nucleotide Polymorphisms, Young adults, Fitness testing

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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 measuresCross-sectional, one-time measure

Secondary

MeasureTime frame
Perception of physical fitness; Relationship between physiological measures and genotype variationCross-sectional, one-time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026