Clinical trial NCT02609243: Diabetes Nutrition Algorithm - Prediabetes
Official title: Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediabetes
Diabetes Mellitus Type 2
Obesity
NAFLD
Dyslipoproteinemia
Keywords: prediabetes
diabetes mellitus type 2
obesity
NAFLD
dyslipoproteinemia
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Diabetes Center
First posted: 2015-11-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
timeFrame: 3 weeks, 6 months, 1 year, 3 years
measure: change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging
timeFrame: 3 weeks, 6 months, 1 year, 3 years
Secondary outcomes:
measure: change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
timeFrame: 3 weeks, 6 months, 1 year, 3 years
measure: change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
timeFrame: 3 weeks, 6 months, 1 year, 3 years
measure: change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager
timeFrame: 3 weeks, 6 months, 1 year, 3 years
Other outcomes:
Locations:
city: Bergholz-Rehbrücke
country: Germany
facility: German Institut for Human Nutrition; Department for Clinical Nutrition
state: Brandenburg
city: Berlin
country: Germany
facility: German Institute for Human Nutrition, Department for Clinical Nutrition
Study officials:
affiliation: German Institute of Human Nutrition
name: Andreas FH Pfeiffer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: