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Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus (DiNA-D)

Primary Purpose

Type 2 Diabetes, NAFLD, Obesity

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

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male and female subjects
  • 18-79 years old
  • type 2 diabetes

Exclusion Criteria:

  • renal insufficiency
  • anaemia
  • immunosuppression
  • previous symptomatic cancer diagnosis
  • acute cardiovascular disease (stroke, coronary syndrome)
  • pregnancy and lactation
  • severe psychiatric disorders
  • corticoid or other immunosuppressive therapy

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

low-carb diet, followed by conventional DGE diet

very-low calory diet, followed by conventional diet

Arm Description

subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)

subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines

Outcomes

Primary Outcome Measures

change in insulin secretion (glucagon stimulation test)
change in insulin secretion (glucagon stimulation test)
change in hepatic fat content (MR-S)
change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter

Secondary Outcome Measures

inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level)
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
peripheral neuropathy
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
autonomic neuropathy

Full Information

First Posted
March 23, 2015
Last Updated
June 23, 2020
Sponsor
German Institute of Human Nutrition
Collaborators
German Center for Diabetes Research, California Walnut Company, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
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1. Study Identification

Unique Protocol Identification Number
NCT02459496
Brief Title
Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
Acronym
DiNA-D
Official Title
Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
German Center for Diabetes Research, California Walnut Company, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
Detailed Description
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, NAFLD, Obesity, Dyslipoproteinaemia, Hypertension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
low-carb diet, followed by conventional DGE diet
Arm Type
Active Comparator
Arm Description
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
Arm Title
very-low calory diet, followed by conventional diet
Arm Type
Active Comparator
Arm Description
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
Intervention Type
Behavioral
Intervention Name(s)
dietary consulting and advise
Intervention Description
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
Primary Outcome Measure Information:
Title
change in insulin secretion (glucagon stimulation test)
Description
change in insulin secretion (glucagon stimulation test)
Time Frame
3 weeks, 1 year
Title
change in hepatic fat content (MR-S)
Description
change in hepatic fat content (MR-S)
Time Frame
3 weeks, 1 year
Title
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Description
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame
3 weeks, 1 year
Title
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
Description
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame
3 weeks, 1 year
Title
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
Description
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame
3 weeks, 1 year
Secondary Outcome Measure Information:
Title
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
Description
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level)
Time Frame
3 weeks, 1 year
Title
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
Description
peripheral neuropathy
Time Frame
3 weeks, 1 year
Title
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
Description
autonomic neuropathy
Time Frame
3 weeks, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male and female subjects 18-79 years old type 2 diabetes Exclusion Criteria: renal insufficiency anaemia immunosuppression previous symptomatic cancer diagnosis acute cardiovascular disease (stroke, coronary syndrome) pregnancy and lactation severe psychiatric disorders corticoid or other immunosuppressive therapy
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@dife.de
First Name & Middle Initial & Last Name or Official Title & Degree
June Inderthal
Phone
033 200 88 2771
Email
june.inderthal@dife.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas F.H. Pfeiffer, Prof. Dr. med.
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
Not yet 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

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Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

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