Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- change in insulin secretion (glucagon stimulation test)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •male and female subjects
- •18-79 years old
- •type 2 diabetes
Exclusion Criteria
- •renal insufficiency
- •immunosuppression
- •previous symptomatic cancer diagnosis
- •acute cardiovascular disease (stroke, coronary syndrome)
- •pregnancy and lactation
- •severe psychiatric disorders
- •corticoid or other immunosuppressive therapy
Outcomes
Primary Outcomes
change in insulin secretion (glucagon stimulation test)
Time Frame: 3 weeks, 1 year
change in insulin secretion (glucagon stimulation test)
change in blood glucose profile 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 hepatic fat content (MR-S)
Time Frame: 3 weeks, 1 year
change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame: 3 weeks, 1 year
change in insulin secretion 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 insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
Secondary Outcomes
- change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)(3 weeks, 1 year)
- 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)
Investigators
Prof. Dr. med. Andreas F. H. Pfeiffer
Director of the Department for Clinical Nutrition
German Institute of Human Nutrition