Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging
研究概览
简要总结
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
详细描述
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design.
Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •impaired fasting glucose (IFG) fasting blood glucose 100-126 mg/dl
- •impaired glucose tolerance (IGT) 75 g OGTT 120 minutes: 140-200 mg/dl
排除标准
- •current pregnancy or breastfeeding
- •BMI > 45 kg/m²
- •Diabetes mellitus Typ 1 or 2
- •serious disease e.g symptomatic coronary heart disease
- •serious symptomatic malignant disease (weight loss > 10% within the last 6 month)
- •severe liver or kidney disease ( an increase in transaminases > 3 times than the upper limit of the standardized range, GFR < 50 ml/min/1,73m²)
- •systemic infection (CRP > 1 mg/dl)
- •severe mental illness
- •drug abuse
- •treatment with steroids
- •potentially incompliant subjects
- •exclusion criteria for magnetic resonance tomography
- •any kind of metal in or on the body: cardiac pacemakers prosthetic heart valves metal prosthesis magnetic implanted metallic parts contraceptive coil metal fragments/ grenade shrapnel fixed braces acupuncture needles insulin pump intraport etc. Field strength > 3 Tesla further tattoos, permanent make-up
- •persons with limited thermosensory or heightened sensitivity to heating
- •persons where cardiovascular disease cannot be ruled out by examination
- •persons with heightened sensitivity to loud noise or diseases of the ear
- •used closed whole body scanner: claustrophobia
研究组 & 干预措施
intensive consulting, conventional diet
subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat ) - dietary intervention without supplement
干预措施: dietary consulting (Behavioral)
conventional consulting, low-carb diet
subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement
干预措施: dietary consulting (Behavioral)
conventional consulting, conventional diet
subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat) - dietary intervention without supplement
干预措施: dietary consulting (Behavioral)
intensive consulting, low-carb diet
subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement
干预措施: dietary consulting (Behavioral)
结局指标
主要结局
change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging
时间窗: 3 weeks, 6 months, 1 year, 3 years
change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
时间窗: 3 weeks, 6 months, 1 year, 3 years
次要结局
- change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)(3 weeks, 6 months, 1 year, 3 years)
- change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager(3 weeks, 6 months, 1 year, 3 years)
- change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)(3 weeks, 6 months, 1 year, 3 years)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Director / Department for Clinical Nutrition
German Institute of Human Nutrition