Dyslipidemia, Hypertension, Metabolic Syndrome, 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. This core comparison is dealt with in the DiNA-D study (published elsewhere). POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.
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 and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere). POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.
Interventions
DIETARY_SUPPLEMENTdiet with/without supplementation
diet with/without supplementation with PUFAs
Sponsors
German Center for Diabetes Research
California Walnut Commission
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 insulin secretion (glucagon stimulation test) | 49 weeks | change in insulin secretion (glucagon stimulation test) |
| change in hepatic fat content (MR-S) | 49 weeks | change in hepatic fat content (MR-S) |
| change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter | 49 weeks | 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 | 49 weeks | change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter |
| change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter | 49 weeks | change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6) | 49 weeks | inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6) |
| change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN) | 49 weeks | change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN) |
| change in parameters of peripheral neuropathy - vibration threshold | 49 weeks | change in parameters of peripheral neuropathy - vibration threshold |
| change in parameters of peripheral neuropathy - thermal sensitivity | 49 weeks | change in parameters of peripheral neuropathy - thermal sensitivity |
| change in parameters of peripheral neuropathy - pain thresholds | 49 weeks | change in parameters of peripheral neuropathy - pain thresholds |
| change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD) | 49 weeks | change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD) |
Countries
Germany
Contacts
Primary ContactStefan Kabisch, Dr. med.
Backup ContactJune Inderthal
Outcome results
None listed