Bioenergetics and Metabolism in Pediatric Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Predicting Type 2 Diabetes development
研究概览
简要总结
The investigators want to learn more about obesity, the development of insulin resistance, and Type 2 Diabetes in children. The investigators will do this through collecting information about children's health and conducting experiments on a variety of samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5-9 years and Tanner stage as reported by parent no greater than stage 1 OR Age 5 years - 17 years 5 months, diagnosed with type 2 diabetes mellitus or insulin resistance
- •Either healthy lean (BMI≥ 5th percentile and <85th percentile for age/sex) or obese (BMI ≥ 95th percentile for age/sex)
- •For those with BMI≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of BMI≥ 95th percentile for age/sex for at least six months prior to study enrollment
- •Exclusion criteria:
- •Genetic or physical conditions impacting mobility over past year as determined by the Principal Investigator (PI)
- •Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
- •Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
- •BMI<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts)
- •Subjects determined ineligible by the PI.
排除标准
- 未提供
结局指标
主要结局
Predicting Type 2 Diabetes development
时间窗: After completion of all study visits, approximately 2 years.
The investigators hypothesize that poor oxidative capacity over time may be predictive of Type 2 Diabetes development.
Bioenergetics in Type 2 Diabetes with metformin
时间窗: 6 months
The investigators hypothesize that the change in bioenergetics will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Alterations in resting energy expenditure
时间窗: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of decreased resting energy expenditure.
Altered circulating blood cell bioenergetics
时间窗: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit altered circulating blood cell bioenergetics.
Oxidized plasma redox state
时间窗: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit a more oxidized plasma redox state.
Alterations in fatty acid oxidation
时间窗: After completion of all study visits, approximately 2 years.
We hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of impaired fatty acid oxidation (FAO).
Fatty Acid Oxidation in Type 2 Diabetes with metformin
时间窗: 6 months
The investigators hypothesize that the change in fatty acid oxidation will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Poor oxidative capacity
时间窗: After completion of all study visits, approximately 2 years.
The investigators hypothesize that poor oxidative capacity over time may distinguish between metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) phenotypes.
Resting Energy Expenditure in Type 2 Diabetes with metformin
时间窗: 6 months
The investigators hypothesize that the change in resting energy expenditure will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
次要结局
未报告次要终点