Assessing Inherited Markers of Metabolic Syndrome in the Young
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eric Hoffman
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
时间窗: Cross-sectional, one-time measure
次要结局
- Perception of physical fitness; Relationship between physiological measures and genotype variation(Cross-sectional, one-time)
研究者
Eric Hoffman
MD
Children's National Research Institute