Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- C-terminal telopeptide of type 1 collagen
研究概览
简要总结
The two specific aims of the study were to determine whether:
- Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;
- Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.
详细描述
The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).
The investigators pursued two hypotheses, that:
- 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and
- Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.
Subjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:
Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week
排除标准
- •metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria
研究组 & 干预措施
Uphill exercise before the meals
40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
干预措施: Behavior intervention of uphill exercise (Combination Product)
Uphill exercise before the meals
40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
干预措施: Dietary intervention of exercise before the meal (Combination Product)
Uphill exercise after the meals
40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
干预措施: Dietary intervention of uphill exercise (Combination Product)
Uphill exercise after the meals
40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
干预措施: Dietary intervention of exercise after the meal (Combination Product)
Downhill exercise before the meals
40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
干预措施: Behavior intervention of downhill exercise (Combination Product)
Downhill exercise before the meals
40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
干预措施: Dietary intervention of exercise before the meal (Combination Product)
Downhill exercise after the meals
40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
干预措施: Behavioral intervention of downhill exercise (Combination Product)
Downhill exercise after the meals
40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
干预措施: Dietary intervention of exercise after the meal (Combination Product)
Sedentary trial
A trial with no exercise
干预措施: Behavioral intervention of sedentary no-exercise trial (Combination Product)
Sedentary trial
A trial with no exercise
干预措施: Dietary intervention of eating two meals (Combination Product)
结局指标
主要结局
C-terminal telopeptide of type 1 collagen
时间窗: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
C-terminal propeptide of type I collagen
时间窗: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
Osteocalcin
时间窗: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of osteocalcin (ng/ml)
Bone-specific alkaline phosphatase
时间窗: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)
次要结局
- Cortisol(Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial)
- Glucose(Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial)
- Insulin(Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial)
- Parathyroid hormone(Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial)
- Dual-energy X-ray radiography(A week prior to the study baseline)
- Growth hormone(Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial)
- Novel Pedar(During two one-hour bouts of the exercise intervention)
研究者
Dr. Katarina Borer
Professor
University of Michigan