Diabetes Nutrition Algorithm - Prediabetes (DiNA-P)
Prediabetes, Diabetes Mellitus Type 2, Obesity
About this trial
This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, diabetes mellitus type 2, obesity, NAFLD, dyslipoproteinemia
Eligibility Criteria
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
- exclusion criteria for magnetic resonance tomography
- any kind of metal in or on the body: cardiac pacemakers prosthetic heart valves metal prosthesis magnetic implanted metallic parts contraceptive coil metal fragments/ grenade shrapnel fixed braces acupuncture needles insulin pump intraport etc. Field strength > 3 Tesla further tattoos, permanent make-up
- persons with limited thermosensory or heightened sensitivity to heating
- persons where cardiovascular disease cannot be ruled out by examination
- persons with heightened sensitivity to loud noise or diseases of the ear
- used closed whole body scanner: claustrophobia
Sites / Locations
- German Institut for Human Nutrition; Department for Clinical NutritionRecruiting
- German Institute for Human Nutrition, Department for Clinical NutritionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
intensive consulting, conventional diet
conventional consulting, low-carb diet
conventional consulting, conventional diet
intensive consulting, low-carb diet
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
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
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
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