Diabetes Mellitus Type 2 Clinical Trial
Official title:
Prediabetes Lifestyle Intervention Study
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.
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.
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