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临床试验/NCT04812314
NCT04812314招募中不适用

Exercise Effects on Adipose Tissue Structure and Function

University of Michigan2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
2
主要终点
Adipose Capillarization

研究概览

简要总结

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

详细描述

Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.

Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-40
  • Body Mass Index: 27-45 kg/m2
  • No regularly planned exercise/physical activity for at least 6 months
  • Women must have regularly occurring menses and must be premenopausal

排除标准

  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism, or inflammation
  • Weight instability ≥ ± 6 pounds in the last 3 months
  • Tobacco or e-cigarette users
  • Women must not be pregnant or actively lactating

研究组 & 干预措施

Exercise

Experimental

This exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week.

干预措施: Exercise (Behavioral)

No exercise

Experimental

Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.

干预措施: No exercise (Behavioral)

结局指标

主要结局

Adipose Capillarization

时间窗: 30 minutes

measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.

Muscle Capillarization

时间窗: 30 minutes

measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.

Adipose Tissue Fibrosis

时间窗: 30 minutes

measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.

Fat Cell Size

时间窗: 3 minutes

measured histologically using Hematoxylin and eosin (H \& E) staining, quantified using ImageJ software at each clinical visit appointment.

Oral Glucose Tolerance Test (OGTT)

时间窗: 2 hours

A test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood will be completed at each clinical visit appointment..

次要结局

  • Blood Lipid Profile(15 minutes)
  • Blood Pressure(10 minutes)

研究者

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

Jeffrey F Horowitz

professor of Movement Science and director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology

University of Michigan

研究点 (2)

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