Diabetes Nutrition Algorithm - Prediabetes (DiNA-P)

German Institute of Human Nutrition

Status: Unknown

Conditions: Prediabetes; Dyslipoproteinemia; Diabetes Mellitus Type 2; Obesity; NAFLD

Treatments: Behavioral: dietary consulting

Study type: Interventional

Funder types: Other

Identifiers

NCT02609243

DiNA-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

intensive consulting, conventional diet

Active Comparator group

Description:

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

Treatment:

Behavioral: dietary consulting

conventional consulting, low-carb diet

Active Comparator group

Description:

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

Treatment:

Behavioral: dietary consulting

conventional consulting, conventional diet

Active Comparator group

Description:

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

Treatment:

Behavioral: dietary consulting

intensive consulting, low-carb diet

Active Comparator group

Description:

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

Treatment:

Behavioral: dietary consulting