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临床试验/NCT03922685
NCT03922685已完成不适用

Control of Postprandial Glycemia: the Roles of Diet and Exercise

University of Michigan0 个研究点目标入组 8 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Postprandial glucose concentration

研究概览

简要总结

Specific aims of the study are:

  1. to evaluate whether a 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h),. and
  2. to determine whether one hour of post-meal moderate intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia.

The outcome measures are: plasma concentrations of glucose, insulin, glucose-dependent-insulinotropic peptide (GIP), leptin, and the ketone body beta-hydroxybutyrate.

详细描述

The two hypotheses in this study are:

  1. A 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h), and
  2. One hour of moderate-intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h).

Eight postmenopausal subjects (age 58.5 years, BMI 25.6 kg/m2) participated in 4 24-h long crossover trials, two terminating at 7h and the other 2 at 19h. At each circadian time one trial required 60 minutes of moderate-intensity exercise (50% of maximal effort), and the other two involved no exercise.

Three 25%-carbohydrate meals prepared by the Michigan Clinical Research Unit (MCRU) kitchen, were eaten at subjects' home, and the fourth was eaten 20 minutes after subjects' arrival at MCRU at either 19 h or 7 h. Blood was collected from antecubital catheter at 10-minute intervals until 23:20 h or 11:20 h, respectively.Plasma was treated with protease inhibitor to preserve GIP, frozen at -80o C until glucose measurements by glucose oxidase, hormone measurements by chemiluminescence, and ketone measurements by Abbott meter strips.

Exercise intensity was determined before the exercise trials on a treadmill from oxygen consumption (VO2) and carbon dioxide production (VCO2) by subjects walking on a treadmill at 3 mph with the treadmill slope increased by 2% every 3 minutes. Maximal effort was established when respiratory exchange ratio (VCO2/VO2) reached or exceeded 1. The treadmill speed and slope at half maximal effort was used during the one-hour exercise bout which was initiated 40 minutes after the start of the meal.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
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

入选标准

  • postmenopausal
  • normal blood glucose
  • no cholesterol medication
  • age between 50 an 65 years
  • overweight but not obese
  • BMI between 25 and 30 kg/m2
  • weight-stable during past 6 months
  • exercise less than 20 minutes three times a week

排除标准

  • metabolic disease other than hormonally-corrected hypothyroidism
  • musculo-skeletal disability that would preclude exercise
  • do not meet inclusion criteria

结局指标

主要结局

Postprandial glucose concentration

时间窗: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials

The area under the postprandial glucose curve

Postprandial insulin concentration

时间窗: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials

The area under the postprandial insulin curve

次要结局

  • Postprandial leptin concentration(Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials)
  • Postprandial glucose-dependent insulinotropic peptide (GIP) concentration(Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials)
  • Postprandial beta-hydroxybutyrate concentration(Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Katarina Borer

Professor

University of Michigan

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