Dyslipoproteinaemia, Hypertension, NAFLD, Obesity, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALdietary 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
Sponsors
German Center for Diabetes Research
California Walnut Company
Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in blood glucose profile 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 hepatic fat content (MR-S) | 3 weeks, 1 year | change in hepatic fat content (MR-S) |
| change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter | 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 | 3 weeks, 1 year | change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter |
| change in insulin secretion (glucagon stimulation test) | 3 weeks, 1 year | change in insulin secretion (glucagon stimulation test) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds | 3 weeks, 1 year | peripheral neuropathy |
| change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD) | 3 weeks, 1 year | autonomic neuropathy |
| inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6) | 3 weeks, 1 year | inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level) |
Countries
Germany
Contacts
Primary ContactStefan Kabisch, Dr. med.
Backup ContactJune Inderthal
Outcome results
None listed