NCT02695810已完成2 期
Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring
研究概览
简要总结
The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).
详细描述
Different medical therapies and lifestyle modification for the prevention of type 2 diabetes have yet to be compared head-to-head in individuals with pre-diabetes. This research project will compare different glucose-lowering interventions in overweight and obese individuals with HbA1c levels in the pre-diabetic range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HbA1c: from ≥5.7% (39 mmol/mol) to ≤6.4% (47 mmol/mol)
- •Age: from ≥30 to ≤70 years of age
- •BMI ≥25 kg/m2
排除标准
- •Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression;
- •Current treatment with hormones which affect glucose metabolism;
- •Current treatment with loop diuretics or thiazolidinediones;
- •Current treatment with beta blockers or peroral steroids;
- •Bariatric surgery within the past 2 years;
- •Impaired renal function defined as an estimated GFR<60 ml/min/1.73m2;
- •Neurogenic bladder disorders;
- •Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion;
- •Pregnant or lactating women;
- •Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices;
- •Allergic to one or more of the medications used in the study;
- •Concomitant participation in other intervention study;
- •Unable to understand the informed consent and the study procedures.
研究组 & 干预措施
Dapagliflozin
Experimental
Dapagliflozin, 10 mg per day
干预措施: Dapagliflozin (Drug)
Metformin
Active Comparator
Metformin, 2 x 850 mg per day
干预措施: Metformin (Drug)
Exercise
Active Comparator
Exercise, interval training
干预措施: Exercise (Behavioral)
结局指标
主要结局
Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring
时间窗: Change from baseline to 13 weeks and 26 weeks
次要结局
- Adherence to the different interventions as assessed by number of tablets returned or number of training passes completed(Change from baseline to 13 weeks and 26 weeks)
- Daily time spent above different glucose concentrations ( e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)(Change from baseline to 13 weeks and 26 weeks)
- HbA1c(Change from baseline to 13 weeks and 26 weeks)
- Insulin secretion as assessed by the insulinogenic index(Change from baseline to 13 weeks and 26 weeks)
- Insulin sensitivity as assessed by the insulin sensitivity index(Change from baseline to 13 weeks and 26 weeks)
- Body weight (kg)(Change from baseline to 13 weeks and 26 weeks)
- Body fat (%) as assessed by DEXA scan(Change from baseline to 13 weeks and 26 weeks)
- Cardiorespiratory fitness as assessed by maximal oxygen uptake (VO2 max)(Change from baseline to 13 weeks and 26 weeks)
- Intra-day glycaemic variability as assessed by continuous overall net glycaemic action (CONGA)(Change from baseline to 13 weeks and 26 weeks)
- Time spent sedentary and in moderate-to-vigorous physical activity intensity as assessed by accelerometer(Change from baseline to 13 weeks and 26 weeks)
- Glucose concentrations during OGTT(Change from baseline to 13 weeks and 26 weeks)
- Respiratory exchange ratio (RER) as assessed by indirect calorimetry(Change from baseline to 13 weeks and 26 weeks)
- Basal metabolic rate (BMR) as assessed by indirect calorimetry(Change from baseline to 13 weeks and 26 weeks)
- Systolic and diastolic blood pressure(Change from baseline to 13 weeks and 26 weeks)
- Sleep habits as assessed by questionnaire(Change from baseline to 13 weeks and 26 weeks)
- Plasma lipids(Change from baseline to 13 weeks and 26 weeks)
- Number of self-reported adverse events and side effects(Change from baseline to 13 weeks and 26 weeks)
- Dietary intake as assessed by a food diary(Change from baseline to 13 weeks and 26 weeks)
- Self-rated health and quality of life as assessed by questionnaire(Change from baseline to 13 weeks and 26 weeks)
- Responsiveness to interventions in individuals with different glucose tolerance status (impaired fasting glycaemia vs. impaired glucose tolerance)(Change from baseline to 13 weeks and 26 weeks)
研究者
Kristine Færch
Senior Researcher
Steno Diabetes Center Copenhagen
研究点 (1)
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