Diabetes Mellitus Type 2
Conditions
Keywords
diabetes mellitus type 2, impaired glucose tolerance, lifestyle intervention, body fat distribution, prevention
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.
Interventions
BEHAVIORALintensified 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)
BEHAVIORALnormal 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)
BEHAVIORALSingle 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
German Diabetes-Center, Leibniz-Institut in Düsseldorf
Endocrinology and Metabolic Diseases, Charité Berlin
German Institute of Human Nutrition
University Hospital Carl Gustav Carus
LMU München, medical clinic IV
University Hospital Heidelberg
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* impaired fasting glucose (IFG) * fasting blood glucose 99-126 mg/dl and/or * 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 * potentially incompliant subjects *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT) | one year | insulin resistance is calculated as follows: * Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0) * ISIest= 10000/²√ ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5)) |
| insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT) | one year | insulin resistance is calculated as follows: * Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0) * ISIest= 10000/²√ ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5)) |
| distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager | one year | — |
Other
| Measure | Time frame |
|---|---|
| metabolic and genetic characterization to determine the risk of type 2 diabetes confirmed by case history, clinical examination, venous blood sampling, DNA isolation, standardised questionnaires, bio-electric impedance analysis (BIA)and ergospirometry | one year |
| metabolic and genetic characterization to determine the non-response to lifestyle intervention confirmed by case history, clinical examination, venous blood sampling, DNA isolation, standardised questionnaires,BIA, ergospirometry | one year |
Countries
Germany
Outcome results
None listed