Diabetes Mellitus Type 2, Dyslipoproteinemia, NAFLD, Obesity, Prediabetes
Conditions
Keywords
prediabetes, diabetes mellitus type 2, obesity, NAFLD, dyslipoproteinemia
Brief summary
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
Detailed description
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement. The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design. Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.
Interventions
BEHAVIORALdietary consulting
dietary consulting implies specific dietary advice based on pre-interventional self-report regarding food intake; consulting focuses on nutrient content, calory intake, weight loss; with regard to randomisation consulting intensity and content varies
Sponsors
German Diabetes Center
German Institute of Human Nutrition
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 100-126 mg/dl and/or * impaired glucose tolerance (IGT) 75 g OGTT 120 minutes: 140-200 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 |
|---|---|
| change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) | 3 weeks, 6 months, 1 year, 3 years |
| change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging | 3 weeks, 6 months, 1 year, 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT) | 3 weeks, 6 months, 1 year, 3 years | 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)) |
| change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT) | 3 weeks, 6 months, 1 year, 3 years | 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)) |
| change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager | 3 weeks, 6 months, 1 year, 3 years | — |
Countries
Germany
Contacts
Primary ContactStefan Kabisch, Dr. med.
Backup ContactMargrit Kemper, Dr.
Outcome results
None listed