Prediabetes Lifestyle Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,145
- 试验地点
- 11
- 主要终点
- postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
研究概览
简要总结
The purpose of this prospective randomized multicenter intervention study is to determine whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a conventional lifestyle intervention in high risk non-Responder subjects. Further, the intensive phenotyping to determine subgroups with an increased risk for diabetes enables an individualized prevention and therapy of type 2 diabetes mellitus.
详细描述
The study start with an intensive phenotyping at baseline (initial examination) to determine subjects with prediabetes. These high risk non-Responder are randomized in two arms (intensified vs normal lifestyle intervention)with equal number of subjects (n=250). The results are compared with each other at the end of the study.
The low risk Responder are randomized in two arms (normal vs. once lifestyle intervention = control group) with equal number of subjects (n=250).
After the screening at baseline the 12 month lifestyle intervention starts for lifestyle intervention groups. The different therapy groups are formed as described before. The subjects with intensified lifestyle intervention get 16 consultations, the subjects with normal lifestyle intervention get 8 consultations, the subjects of the control group get one consultation to learn more about a healthier lifestyle. During the whole study there is a continuous supervision from physician and nutritional advisers and the subjects have to document a nutrition and an exercise protocol as well as subjective measurements. At baseline, after 24 weeks and at follow up 1, 2 and 3 years later there is an elaborate metabolic characterization of all subjects (also the Responder groups) a 75 g venous oral glucose tolerance test (OGTT) as well as an analysis of the distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager.
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 99-126 mg/dl
- •impaired glucose tolerance (IGT)
- •75 g OGTT 120 minutes: 139-200 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
- •Additional for spirometry
- •acute coronary syndrome
- •higher cardiac arrhythmia
- •decompensated heart failure
- •acute carditis
- •pulmonary embolism
- •acute deep leg vein thrombosis ( phlebothrombosis)
- •hyperthyroidism (TSH)
- •hypokalemia
结局指标
主要结局
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
时间窗: one year
次要结局
- distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager(one year)
- insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)(one year)
- insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)(one year)
研究者
andreas fritsche
Prof. Dr. med. Andreas Fritsche
University Hospital Tuebingen