Individualized Lifestyle Intervention in Subjects With Prediabetes

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.

Conditions

• Diabetes Mellitus Type 2

Interventions

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)

Sponsors & Collaborators

• German Diabetes-Center, Leibniz-Institut in Düsseldorf

  collaborator OTHER

• Endocrinology and Metabolic Diseases, Charité Berlin

  collaborator UNKNOWN

• German Institute of Human Nutrition

  collaborator OTHER

• University Hospital Carl Gustav Carus

  collaborator OTHER

• LMU München, medical clinic IV

  collaborator UNKNOWN

• University Hospital Heidelberg

  collaborator OTHER

• University Hospital Tuebingen

  lead OTHER

Principal Investigators

• Andreas Fritsche, Prof. Dr. med · University Hospital Tuebingen

• Norbert Stefan, Prof.Dr.med. · University Hospital Tübingen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• Germany

Study Locations