NCT01947595

Individualized Lifestyle Intervention in Subjects With Prediabetes

Prediabetes Lifestyle Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,145 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
BEHAVIORAL	intensified lifestyle intervention	* 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)
BEHAVIORAL	normal lifestyle intervention	* 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)
BEHAVIORAL	Single lifestyle advice	\- Single Health care advice and lifestyle advice (30 minutes) at the beginning * recommend the individual target weight (5% less, if BMI 25\> kg/m²)

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2013-09-20
• Last updated: 2017-08-23

Locations

7 sites across 1 country: Germany