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

Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obesity; Type 2 Diabetes; NAFLD; Dyslipoproteinaemia
• Intervention / Treatment: Behavioral: dietary consulting and advise

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Kabisch, Dr. med.; Phone Number: 429 030 450 514; Email: stefan.kabisch@dife.de
• Study Contact Backup: Name: June Inderthal; Phone Number: 033 200 88 2771; Email: june.inderthal@dife.de

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
      • Not yet 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 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in insulin secretion (glucagon stimulation test)	change in insulin secretion (glucagon stimulation test)	3 weeks, 1 year
change in hepatic fat content (MR-S)	change in hepatic fat content (MR-S)	3 weeks, 1 year
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	3 weeks, 1 year
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	3 weeks, 1 year
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	3 weeks, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 weeks, 1 year
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds	peripheral neuropathy	3 weeks, 1 year
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)	autonomic neuropathy	3 weeks, 1 year

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: German Center for Diabetes Research; Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV); California Walnut Company
• Investigators: Principal Investigator: Andreas F.H. Pfeiffer, Prof. Dr. med., German Institute of Human Nutrition

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 2, 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

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: DiNA-D