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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02459496
Other study ID # DiNA-D
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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