NCT01513798已完成不适用
Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fat mass
研究概览
简要总结
The investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. The investigators randomize 40 participants to two groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2) Modified paleolithic diet and general advice about exercise.
The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes less than 10 years
- •BMI 27-35
- •women only after menopause
- •diabetes treatment with diet and/or metformin
- •HbA1c between 45 and 94
排除标准
- •nicotine use
- •betablockers
- •estrogens orally
- •blod pressure >160/100
- •macroalbuminuria
- •malignancy during the past 5 years
- •alcoholism
- •depression
- •cardiovascular disease/stroke
- •liver disease
- •serious lung disease, GI disease or kidney disease
- •more than 30 minutes/5 days a week of moderate exercise during the last 6 months
- •resistance training during the past 6 months
- •official weight loosing program during the past year
- •obesity surgery
- •night work
- •MADRS-S (Montgomery Asberg Depression Rating Scale) >20 points
- •AUDIT >14 points for women, >16 points for men
- •not possible to obtain venous sampling
结局指标
主要结局
Fat mass
时间窗: Baseline - 12 weeks
Measured with DEXA (dual energy x-ray absorptiometry)
次要结局
- Hepatic insulin sensitivity(Baseline - 12 weeks)
- Appetite regulation(Baseline - 12 weeks)
- Dopamine 2-receptors in striatum(Baseline - 12 weeks)
- Anaerobic Threshold(Baseline - 12 weeks)
- Substrate utilization during submaximal exercise(Baseline - 12 weeks)
- Liver fat(Baseline - 12 weeks)
- Cortisol turnover(Baseline - 12 weeks)
- Executive ability and memory(Baseline - 12 weeks)
- Validity of energy intake and protein intake(Baseline - 6 weeks - 12 weeks)
- Oxygen Uptake(Baseline - 12 weeks)
- Peripheral insulin sensitivity(Baseline - 12 weeks)
- Experience of training(Baseline - 12 weeks)
研究者
研究点 (2)
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