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| Name | Class |
|---|---|
| German Center for Diabetes Research | OTHER |
| California Walnut Commission | OTHER |
| Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-carb with PUFA | Active Comparator | 49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins |
|
| low-carb without PUFA | Active Comparator | 49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), without walnuts / walnut-sunflower muffins |
|
| low-fat with PUFA | Active Comparator | 49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins |
|
| low-fat without PUFA | Active Comparator | 49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), without walnuts / walnut-sunflower muffins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet with/without supplementation | Dietary Supplement | diet with/without supplementation with PUFAs |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in insulin secretion (glucagon stimulation test) | change in insulin secretion (glucagon stimulation test) | 49 weeks |
| change in hepatic fat content (MR-S) | change in hepatic fat content (MR-S) | 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 | 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 | 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 | 49 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 49 weeks |
| change in parameters of peripheral neuropathy - vibration threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Kabisch, Dr. med. | Contact | 030 450 514 429 | stefan.kabisch@dife.de | |
| June Inderthal | Contact | 033200 88 2771 | june.inderthal@dife.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas FH Pfeiffer, Prof. Dr. med. | DIfE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIfE (German Institute for Human Nutrition) | Recruiting | Berlin | 12203 | Germany |
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change in parameters of peripheral neuropathy - vibration threshold |
| 49 weeks |
| change in parameters of peripheral neuropathy - thermal sensitivity | change in parameters of peripheral neuropathy - thermal sensitivity | 49 weeks |
| change in parameters of peripheral neuropathy - pain thresholds | change in parameters of peripheral neuropathy - pain thresholds | 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) | 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) | 49 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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