Prediabetes Lifestyle Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 1145
- Locations
- 7
- Primary Endpoint
- postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
andreas fritsche
Prof. Dr. med. Andreas Fritsche
University Hospital Tuebingen
Eligibility Criteria
Inclusion Criteria
- •impaired fasting glucose (IFG)
- •fasting blood glucose 99-126 mg/dl
- •impaired glucose tolerance (IGT)
- •75 g OGTT 120 minutes: 139-200 mg/dl
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
Time Frame: one year
Secondary Outcomes
- 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)