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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, Germany
NOT_YET_RECRUITINGGerman Institute for Human Nutrition, Department for Clinical Nutrition
Berlin, Germany
RECRUITINGchange in insulin secretion (glucagon stimulation test)
change in insulin secretion (glucagon stimulation test)
Time frame: 3 weeks, 1 year
change in hepatic fat content (MR-S)
change in hepatic fat content (MR-S)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 weeks, 1 year
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)
Time frame: 3 weeks, 1 year
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
peripheral neuropathy
Time frame: 3 weeks, 1 year
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
autonomic neuropathy
Time frame: 3 weeks, 1 year
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