Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention
研究概览
简要总结
Elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. This study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels of the branched-chain amino acids may contribute to the development of insulin resistance and ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as insulin sensitivity improves. This information will be used to further our understanding of the development of insulin resistance and type 2 diabetes in at-risk populations and potentially improve clinical treatment of such conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lean and Overweight Pre-diabetic (PD) groups: 40-65 years
- •Obese Gastric Bypass (GBP) patients: 30-65 years
- •Body Mass Index (BMI) within desired range for group:
- •Lean group: 18.0 - 24.9
- •Overweight PD group: 25.0 - 35.4
- •GBP group: 35.0 - 50.0
- •Fasting Plasma Glucose level within desired range for group:
- •Lean: < 99 mg/dL
- •PD: > 105 - < 126 mg/dL
- •GBP: > 99
- •Oral Glucose Tolerance Test, 2-hour Plasma Glucose results within desired range:
- •Lean: < 139 mg/dL
- •PD: 140-199 mg/dL
- •Low density (LDL) cholesterol: < 190 mg/dL
- •Triglycerides: < 600 mg/dL
- •Resting blood pressure: <160/90 mmHg
- •Inactive: Exercise < two days/week (GBP and PD only);
- •Peak oxygen use: > 14.0 - < 40.0 ml/kg/min (PD only)
- •Medications: Stable use of all medications for > three months
- •Body Weight < 495 lbs
排除标准
- •Smoker: Tobacco use within the last 12 months
- •Dieting or intending to diet (excluding intention for gastric bypass procedure in GBP group)- Not weight stable for > six months or weight loss exceeding five pounds in last six months
- •Use of potential confounding medications, e.g. Niacin containing drugs
- •History of diabetes, heart disease or taking medication for those conditions
- •History of hypertension (high blood pressure) not controlled with medication
- •Pregnant or intending to become pregnant
- •Unwillingness to participate in study visits, submit to skeletal muscle biopsies and all other study testing or continuously participate in the exercise training intervention program for six months if in overweight PD group
- •Orthopedic limitations, musculoskeletal disease and/or injury
- •Allergic to xylocaine
- •Inability to give blood continuously through an intravenous catheter
- •Unwillingness to exercise at least three times per week at the Duke Center for Living during staff supervised times (PD only)
- •Exercise compliance less than 85% in any 6 week period (missing > 3 exercise sessions in a 6 week period)
结局指标
主要结局
Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention
时间窗: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery
1. Lean Healthy Controls - Baseline only 2. Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention 3. Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery
次要结局
- Changes in Insulin Sensitivity at Baseline and post-intervention(Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery)