NCT01455441已完成4 期
Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?
Tina Vilsboll2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.
Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed oral and written consent
- •Diagnosed with type 2 diabetes according to the criteria of the WHO
- •HbA1C: 7-11% (doing treatment with diet and/or metformin)
- •Age >18 years
- •BMI >25 kg/m2 <40 kg/m2
- •Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies
排除标准
- •Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures.
- •Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones
- •Ongoing abuse of alcohol or narcotics
- •Impaired hepatic function (liver transaminases >2 times upper normal limit)
- •Impaired renal function (se-creatinine >150μM and/or albuminuria)
- •Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
- •Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
- •Any condition that the investigators feels would interfere with trial participation
- •Receiving any investigational drug within the last 3 months
结局指标
主要结局
HbA1c
时间窗: 16 weeks
Change in HbA1c from baseline to 16 weeks. Glycated haemoglobin (HbA1c) is a form of haemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time (12 weeks).
次要结局
- Blood pressure(16 weeks)
- Glycaemic control(16 weeks)
- Myocardial echocardiography(16 weeks)
- Maximal oxygen uptake (VO2peak)(16 weeks)
- Body weight(16 weeks)
- Meal test(16 weeks)
研究者
Tina Vilsboll
Professor dr.med
University Hospital, Gentofte, Copenhagen
研究点 (2)
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