Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

Obesity Clinical Trial

— DiNA-D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02459496
• Other study ID #: DiNA-D
• Status: Recruiting
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: German Institute of Human Nutrition
• Contact: Stefan Kabisch, Dr. med.
• Phone: 030 450 514
• Email: stefan.kabisch[@]dife.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Dyslipoproteinaemia
• Hypertension
• NAFLD
• Obesity
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Germany	German Institut for Human Nutrition; Department for Clinical Nutrition	Bergholz-Rehbrücke	Brandenburg
Germany	German Institute for Human Nutrition, Department for Clinical Nutrition	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	California Walnut Company, German Center for Diabetes Research, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in insulin secretion (glucagon stimulation test)	change in insulin secretion (glucagon stimulation test)	3 weeks, 1 year
Primary	change in hepatic fat content (MR-S)	change in hepatic fat content (MR-S)	3 weeks, 1 year
Primary	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
Primary	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
Primary	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	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
Secondary	change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds	peripheral neuropathy	3 weeks, 1 year
Secondary	change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)	autonomic neuropathy	3 weeks, 1 year