Diabetes Nutrition Algorithm - Prediabetes (DiNA-P)

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Diabetes Mellitus Type 2; NAFLD; Prediabetes; Dyslipoproteinemia
• Intervention / Treatment: Behavioral: dietary consulting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • German Institute for Human Nutrition, Department for Clinical Nutrition
    • Contact: Stefan Kabisch, Dr. med.; Phone Number: 429 030 450 514; Email: stefan.kabisch@charite.de
    • Contact: Ulrike Kaiser, M.sc.; Phone Number: 428 030 450 514; Email: ulrike.kaiser@charite.de
    • Sub-Investigator: Stefan Kabisch, Dr. med.
    • Sub-Investigator: Ulrike Kaiser, M.sc.
  • Brandenburg
    • Bergholz-Rehbrücke, Brandenburg, Germany, 14458
      • Recruiting
      • German Institut for Human Nutrition; Department for Clinical Nutrition
      • Contact: Margrit Kemper, Dr. med.; Phone Number: 033200 88 2775; Email: margrit.kemper@dife.de
      • Contact: Silke Hornemann; Phone Number: 033200 88 2779; Email: silke.hornemann@dife.de
      • Sub-Investigator: Margrit Kemper, Dr. med.
      • Sub-Investigator: Silke Hornemann
      • Sub-Investigator: Christiana Gerbracht, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: German Diabetes Center
• Investigators: Principal Investigator: Andreas FH Pfeiffer, Prof. Dr., German Institute of Human Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: obesity; NAFLD; prediabetes; diabetes mellitus type 2; dyslipoproteinemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance; Dyslipidemias
• Other Study ID Numbers: DiNA-P