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| Name | Class |
|---|---|
| German Center for Diabetes Research | OTHER |
| California Walnut Company | 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-carb diet, followed by conventional DGE diet | Active Comparator | subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day) |
|
| very-low calory diet, followed by conventional diet | Active Comparator | subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary consulting and advise | Behavioral | first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in insulin secretion (glucagon stimulation test) | change in insulin secretion (glucagon stimulation test) | 3 weeks, 1 year |
| change in hepatic fat content (MR-S) | change in hepatic fat content (MR-S) | 3 weeks, 1 year |
| 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 | 3 weeks, 1 year |
| 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 | 3 weeks, 1 year |
| 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 | 3 weeks, 1 year |
| 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) | 3 weeks, 1 year |
| change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds |
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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 | 033 200 88 2771 | june.inderthal@dife.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas F.H. Pfeiffer, Prof. Dr. med. | German Institute of Human Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institut for Human Nutrition; Department for Clinical Nutrition | Not yet recruiting | Bergholz-Rehbrücke | Brandenburg | 14458 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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peripheral neuropathy |
| 3 weeks, 1 year |
| change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD) | autonomic neuropathy | 3 weeks, 1 year |
| German Institute for Human Nutrition, Department for Clinical Nutrition | Recruiting | Berlin | 12203 | Germany |
|
| 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 |