Individualized Lifestyle Intervention in Subjects With Prediabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Prediabetic State; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): intensified lifestyle intervention; normal lifestyle intervention; Single lifestyle advice
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): physical activity 6 hours per week, 50% guided activity
recorded by an accelerometer (Aipermotion 440)
16 sessions per year with a lifestyle advisor
nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl); physical activity 3 hours per week
recorded by an accelerometer (Aipermotion 440)
8 sessions per year with a lifestyle advisor
nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl); - Single Health care advice and lifestyle advice (30 minutes) at the beginning
recommend the individual target weight (5% less, if BMI 25> kg/m²)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetes mellitus type 2; impaired glucose tolerance; lifestyle intervention; body fat distribution; prevention