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Diabetes Nutrition Algorithm - Prediabetes (DiNA-P)

Primary Purpose

Prediabetes, Diabetes Mellitus Type 2, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
dietary consulting
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, diabetes mellitus type 2, obesity, NAFLD, dyslipoproteinemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • German Institut for Human Nutrition; Department for Clinical NutritionRecruiting
  • German Institute for Human Nutrition, Department for Clinical NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

intensive consulting, conventional diet

conventional consulting, low-carb diet

conventional consulting, conventional diet

intensive consulting, low-carb diet

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging

Secondary Outcome Measures

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))
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))
change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager

Full Information

First Posted
March 23, 2015
Last Updated
June 23, 2020
Sponsor
German Institute of Human Nutrition
Collaborators
German Diabetes Center
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1. Study Identification

Unique Protocol Identification Number
NCT02609243
Brief Title
Diabetes Nutrition Algorithm - Prediabetes
Acronym
DiNA-P
Official Title
Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
German Diabetes Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Diabetes Mellitus Type 2, Obesity, NAFLD, Dyslipoproteinemia
Keywords
prediabetes, diabetes mellitus type 2, obesity, NAFLD, dyslipoproteinemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intensive consulting, conventional diet
Arm Type
Active Comparator
Arm 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
Arm Title
conventional consulting, low-carb diet
Arm Type
Active Comparator
Arm 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
Arm Title
conventional consulting, conventional diet
Arm Type
Active Comparator
Arm 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
Arm Title
intensive consulting, low-carb diet
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
dietary consulting
Other Intervention Name(s)
dietary intervention without supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
Description
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))
Time Frame
3 weeks, 6 months, 1 year, 3 years
Title
change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
Description
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))
Time Frame
3 weeks, 6 months, 1 year, 3 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Kabisch, Dr. med.
Phone
030 450 514
Ext
429
Email
stefan.kabisch@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Margrit Kemper, Dr.
Phone
033200 88 2775
Email
margrit.kemper@dife.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas FH Pfeiffer, Prof. Dr.
Organizational Affiliation
German Institute of Human Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Institut for Human Nutrition; Department for Clinical Nutrition
City
Bergholz-Rehbrücke
State/Province
Brandenburg
ZIP/Postal Code
14458
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margrit Kemper, Dr. med.
Phone
033200 88 2775
Email
margrit.kemper@dife.de
First Name & Middle Initial & Last Name & Degree
Silke Hornemann
Phone
033200 88 2779
Email
silke.hornemann@dife.de
First Name & Middle Initial & Last Name & Degree
Margrit Kemper, Dr. med.
First Name & Middle Initial & Last Name & Degree
Silke Hornemann
First Name & Middle Initial & Last Name & Degree
Christiana Gerbracht, Dr.
Facility Name
German Institute for Human Nutrition, Department for Clinical Nutrition
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kabisch, Dr. med.
Phone
030 450 514
Ext
429
Email
stefan.kabisch@charite.de
First Name & Middle Initial & Last Name & Degree
Ulrike Kaiser, M.sc.
Phone
030 450 514
Ext
428
Email
ulrike.kaiser@charite.de
First Name & Middle Initial & Last Name & Degree
Stefan Kabisch, Dr. med.
First Name & Middle Initial & Last Name & Degree
Ulrike Kaiser, M.sc.

12. IPD Sharing Statement

Learn more about this trial

Diabetes Nutrition Algorithm - Prediabetes

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