Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

NCT02459496 | Unknown DMC

• 1 other identifier: DiNA-D
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes; NAFLD; Obesity; Dyslipoproteinaemia; Hypertension

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)

  3 weeks, 1 year

• change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds

  3 weeks, 1 year

• change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)

  3 weeks, 1 year

Study Arms (2)

low-carb diet, followed by conventional DGE diet

ACTIVE COMPARATOR

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

very-low calory diet, followed by conventional diet

ACTIVE COMPARATOR

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

Interventions

dietary consulting and advise BEHAVIORAL

first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines

low-carb diet, followed by conventional DGE diet; very-low calory diet, followed by conventional diet

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female subjects
• years old
• type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• German Center for Diabetes Research: collaborator
• California Walnut Company: collaborator
• Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV): collaborator

Study Sites (2)

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

NOT YET RECRUITING

German Institute for Human Nutrition, Department for Clinical Nutrition

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Obesity; Dyslipidemias; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas F.H. Pfeiffer, Prof. Dr. med.

  German Institute of Human Nutrition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Kabisch, Dr. med.

CONTACT

030 450 514; stefan.kabisch@dife.de

June Inderthal

CONTACT

033 200 88 2771; june.inderthal@dife.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department for Clinical Nutrition

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: June 2, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

DE (2)