Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in HbA1c level.
研究概览
简要总结
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on metabolic parameters, physical measures, fitness level, body composition and miRNA-143 level in patients with type 2 diabetes mellitus.
详细描述
Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, fitness level measured by exercise testing, body composition measured by bioimpedance, metabolic parameters such as blood glucose level, HbA1C and measured by blood tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants wil be making exercise. It is not possible to make participants blinded to the study.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
- •Participants must have appropriate medical therapy and diet.
- •Participants must not be treated with insulin.
- •Participants must be exercising less than 210 minutes/ week.
排除标准
- •Participants with prominent cardiovascular disease
- •Participants with coronary artery disease
- •Participants with moderate to severe valvular disease
- •Participants with atrial fibrillation
- •Participants with untreated hypertension
- •Participants with congenital heart disease
- •Participants with retinopathy
- •Participants with neuropathy
- •Participants with macro albuminuria
- •Participants with cerebrovascular disease
- •Participants with ejection fraction less than 40
- •Participants with body mass index greater than
- •Participants with prominent ischemic changes in EKG at rest or during exercise.
- •Participants with cigarette or alcohol addiction
- •Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones)
结局指标
主要结局
Change in HbA1c level.
时间窗: 12 weeks
Change in HbA1c level measured in the blood after exercise compared to beginning
次要结局
未报告次要终点
研究者
GULIN FINDIKOGLU
Associate Professor, MD, PhD
Pamukkale University