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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
diet with/without supplementation with PUFAs
DIfE (German Institute for Human Nutrition)
Berlin, Germany
RECRUITINGchange in insulin secretion (glucagon stimulation test)
change in insulin secretion (glucagon stimulation test)
Time frame: 49 weeks
change in hepatic fat content (MR-S)
change in hepatic fat content (MR-S)
Time frame: 49 weeks
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: 49 weeks
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: 49 weeks
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: 49 weeks
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 - IL-1; IL1beta, IL-6)
Time frame: 49 weeks
change in parameters of peripheral neuropathy - vibration threshold
change in parameters of peripheral neuropathy - vibration threshold
Time frame: 49 weeks
change in parameters of peripheral neuropathy - thermal sensitivity
change in parameters of peripheral neuropathy - thermal sensitivity
Time frame: 49 weeks
change in parameters of peripheral neuropathy - pain thresholds
change in parameters of peripheral neuropathy - pain thresholds
Time frame: 49 weeks
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)
Time frame: 49 weeks
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
Time frame: 49 weeks
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