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

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ClinicalTrials.gov Identifier: NCT02459496
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : November 22, 2016
Sponsor:
Collaborators:
German Center for Diabetes Research
California Walnut Company
Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

Tracking Information
First Submitted Date  ICMJE March 23, 2015
First Posted Date  ICMJE June 2, 2015
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • change in insulin secretion (glucagon stimulation test) [ Time Frame: 3 weeks, 1 year ]
    change in insulin secretion (glucagon stimulation test)
  • change in hepatic fat content (MR-S) [ Time Frame: 3 weeks, 1 year ]
    change in hepatic fat content (MR-S)
  • change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter [ Time Frame: 3 weeks, 1 year ]
    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 [ Time Frame: 3 weeks, 1 year ]
    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 [ Time Frame: 3 weeks, 1 year ]
    change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02459496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6) [ Time Frame: 3 weeks, 1 year ]
    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 [ Time Frame: 3 weeks, 1 year ]
    peripheral neuropathy
  • change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD) [ Time Frame: 3 weeks, 1 year ]
    autonomic neuropathy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
Official Title  ICMJE Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • NAFLD
  • Obesity
  • Dyslipoproteinaemia
  • Hypertension
Intervention  ICMJE Behavioral: dietary consulting and advise
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
Study Arms  ICMJE
  • Active Comparator: low-carb diet, followed by conventional DGE diet
    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)
    Intervention: Behavioral: dietary consulting and advise
  • Active Comparator: very-low calory diet, followed by conventional diet
    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: Behavioral: dietary consulting and advise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stefan Kabisch, Dr. med. 030 450 514 ext 429 stefan.kabisch@dife.de
Contact: June Inderthal 033 200 88 2771 june.inderthal@dife.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02459496
Other Study ID Numbers  ICMJE DiNA-D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
Study Sponsor  ICMJE German Institute of Human Nutrition
Collaborators  ICMJE
  • German Center for Diabetes Research
  • California Walnut Company
  • Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
Investigators  ICMJE
Principal Investigator: Andreas F.H. Pfeiffer, Prof. Dr. med. German Institute of Human Nutrition
PRS Account German Institute of Human Nutrition
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP