Effects of 12 Weeks of Endurance Exercise Training Alone or in Combination With Glucagon Like Peptide 1 Receptor Agonist (GLP-1 RA) Treatment on Insulin Secretory Capacity in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insulin secretion
研究概览
简要总结
The purpose of this study is to determine the effect of endurance exercise on insulin secretory capacity, alone or in addition to treatment with the glucagon-like-peptide receptor agonist semaglutide, in patients with type 2 diabetes.
详细描述
The effects of endurance exercise alone or in addition to treatment with glucagon-like- peptide receptor agonists on insulin secretory capacity, will be determined in patients with type 2 diabetes.
Included patients will be randomized to either 12 weeks of endurance exercise training 3 times a week or therapeutical treatment with semaglutide for 3 months followed by 12 weeks of endurance exercise training 3 times a week. Insulin secretory capacity will be determined by hyperglycemic clamp method before and after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes
- •BMI 28-35
- •Moderately preserved insulin secretory capacity (determined by glucagon test)
排除标准
- •Insulin treatment
- •Hypertension grade 3
- •Heart disease
- •Medical history with pancreatitis
- •Diagnosed with neuropathy
- •Excessive alcohol consumption
- •Any condition that would interfere with the protocol.
研究组 & 干预措施
Semaglutide treatment
3 months of therapeutic semaglutide treatment
干预措施: Semaglutide (Drug)
Semaglutide and Endurance exercise
12 weeks of endurance exercise concomitant to semaglutide treatment
干预措施: Endurance exercise training (Behavioral)
Semaglutide and Endurance exercise
12 weeks of endurance exercise concomitant to semaglutide treatment
干预措施: Semaglutide (Drug)
Endurance exercise
12 weeks of endurance exercise
干预措施: Endurance exercise training (Behavioral)
结局指标
主要结局
Insulin secretion
时间窗: Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment
By hyperglycemic clamp
次要结局
- Changes in plasma bone markers(Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment)
- Insulin secretion(Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment)
- insulin sensitivity(Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment)
- Cardiorespiratory fitness(Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment)
- Glucose homeostasis(Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment)
- Body composition(Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment)
研究者
Flemming Dela
Professor
University of Copenhagen