DiNA-P: Diabetes Nutrition Algorithm - Prediabetes

Sponsor

German Institute of Human Nutrition (Other)

Overall Status

Unknown status

CT.gov ID

NCT02609243

Collaborator

German Diabetes Center (Other)

250

Enrollment

Locations

Arms

101

Anticipated Duration (Months)

125

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetes Diabetes Mellitus Type 2 Obesity NAFLD Dyslipoproteinemia	Behavioral: dietary consulting	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)

Actual Study Start Date :

Jul 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intensive consulting, conventional 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	Behavioral: dietary 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 Other Names: dietary intervention without supplement
Active Comparator: conventional consulting, low-carb diet 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	Behavioral: dietary 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 Other Names: dietary intervention without supplement
Active Comparator: conventional consulting, conventional diet 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	Behavioral: dietary 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 Other Names: dietary intervention without supplement
Active Comparator: intensive consulting, low-carb diet 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	Behavioral: dietary 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 Other Names: dietary intervention without supplement

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Institut for Human Nutrition; Department for Clinical Nutrition	Bergholz-Rehbrücke	Brandenburg	Germany	14458
2	German Institute for Human Nutrition, Department for Clinical Nutrition	Berlin		Germany	12203