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| Name | Class |
|---|---|
| German Diabetes Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive consulting, conventional diet | Active Comparator | subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat ) - dietary intervention without supplement |
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| conventional consulting, low-carb diet | Active Comparator | subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement |
|
| conventional consulting, conventional diet | Active Comparator | subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat) - dietary intervention without supplement |
|
| intensive consulting, low-carb diet | Active Comparator | subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary consulting | Behavioral | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT) | 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)) | 3 weeks, 6 months, 1 year, 3 years |
| change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT) |
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Inclusion Criteria:
and/or
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Kabisch, Dr. med. | Contact | 030 450 514 | 429 | stefan.kabisch@charite.de |
| Margrit Kemper, Dr. | Contact | 033200 88 2775 | margrit.kemper@dife.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas FH Pfeiffer, Prof. Dr. | German Institute of Human Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institut for Human Nutrition; Department for Clinical Nutrition | Recruiting | Bergholz-Rehbrücke | Brandenburg | 14458 | Germany |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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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)) |
| 3 weeks, 6 months, 1 year, 3 years |
| change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager | 3 weeks, 6 months, 1 year, 3 years |
| German Institute for Human Nutrition, Department for Clinical Nutrition | Recruiting | Berlin | 12203 | Germany |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D052439 | Lipid Metabolism Disorders |