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Diabetes Nutrition Algorithm - Prediabetes (DiNA-P)

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ClinicalTrials.gov Identifier: NCT02609243
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
German Diabetes Center
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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 Name: 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 Name: 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 Name: 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 Name: dietary intervention without supplement




Primary Outcome Measures :
  1. change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) [ Time Frame: 3 weeks, 6 months, 1 year, 3 years ]
  2. change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging [ Time Frame: 3 weeks, 6 months, 1 year, 3 years ]

Secondary Outcome Measures :
  1. change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT) [ Time Frame: 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))


  2. change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT) [ Time Frame: 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))


  3. change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager [ Time Frame: 3 weeks, 6 months, 1 year, 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609243


Contacts
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Contact: Stefan Kabisch, Dr. med. 030 450 514 ext 429 stefan.kabisch@charite.de
Contact: Margrit Kemper, Dr. 033200 88 2775 margrit.kemper@dife.de

Locations
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Germany
German Institut for Human Nutrition; Department for Clinical Nutrition Recruiting
Nuthetal, Brandenburg, Germany, 14458
Contact: Margrit Kemper, Dr. med.    033200 88 2775    margrit.kemper@dife.de   
Contact: Silke Hornemann    033200 88 2779    silke.hornemann@dife.de   
Sub-Investigator: Margrit Kemper, Dr. med.         
Sub-Investigator: Silke Hornemann         
Sub-Investigator: Christiana Gerbracht, Dr.         
German Institute for Human Nutrition, Department for Clinical Nutrition Recruiting
Berlin, Germany, 12203
Contact: Stefan Kabisch, Dr. med.    030 450 514 ext 429    stefan.kabisch@charite.de   
Contact: Ulrike Kaiser, M.sc.    030 450 514 ext 428    ulrike.kaiser@charite.de   
Sub-Investigator: Stefan Kabisch, Dr. med.         
Sub-Investigator: Ulrike Kaiser, M.sc.         
Sponsors and Collaborators
German Institute of Human Nutrition
German Diabetes Center
Investigators
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Principal Investigator: Andreas FH Pfeiffer, Prof. Dr. German Institute of Human Nutrition

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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Director / Department for Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT02609243    
Other Study ID Numbers: DiNA-P
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
prediabetes
diabetes mellitus type 2
obesity
NAFLD
dyslipoproteinemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Lipid Metabolism Disorders