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Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2 diabetes.
This study aims to explore the effect of diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.
This study is a randomised, multicenter controlled trial Our Aim is to test the effects of an 8-week diet lacking red meat, containing increased fibers and coffee (verum) versus standard recommendation (control)in a multicenter setting.
We are expecting that the verum diet will improve insulin sensitivity and insulin secretion due to reductions in visceral and hepatic fat along with improved adipocyte cytokine secretion profiles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypocaloric diet containing increased fibers and coffee | Experimental | In the intervention group the patients are allowed to eat only white meat and fish. They also need to increase their daily fiber intake to 50grams and drink 5 cups of coffee a day. |
|
| hypocaloric diet containing red meat | Active Comparator | control group (n=20): diet according to the ADA/EASD guidelines (50% carbohydrates, 20% proteins, 30% fat). In the control group the patients should eat 150 grams of red meat a day and are not allowed to consume alcohol, coffee and whole grains. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet intervention | Dietary Supplement | 8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| whole body insulin sensitivity | measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| total body fat | MRI measurement of the effects of 8-week diet intervention on total body fat | 8 weeks |
| intramyocellular lipids | MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Roden, MD | German Diabetes Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Diabetes Center | Düsseldorf | North Rhine-Westphalia | 40225 | Germany | ||
| Charite, Department of Internal Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40090039 | Derived | Pafili K, Zaharia OP, Strassburger K, Knebel B, Herder C, Huttasch M, Karusheva Y, Kabisch S, Strom A, Nowotny B, Szendroedi J, Roden M. PNPLA3 gene variation modulates diet-induced improvement in liver lipid content in type 2 diabetes. Clin Nutr. 2025 May;48:6-15. doi: 10.1016/j.clnu.2025.02.032. Epub 2025 Mar 6. | |
| 30619502 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 8 weeks |
| skeletal muscle mitochondrial function - insulin signaling | muscle biopsy for assessment of insulin signaling | 8 weeks |
| hepatocellular lipids | MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL) | 8 weeks |
| skeletal muscle mitochondrial function - phosphate-recovery time | skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS | 8 weeks |
| insulin secretion | measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test | 8 weeks |
| pancreatic fat | MRI measurement of the effects of 8-week diet intervention on pancreatic fat | 8 weeks |
| Berlin |
| Germany |
| University Hospital, Department of Internal Medicine III | Dresden | Germany |
| University Hospital, Department of Internal Medicine I | Heidelberg | Germany |
| Klinikum der Universität München (KUM) | Munich | Germany |
| University Hospital, Department of Internal Medicine IV | Tübingen | Germany |
| Karusheva Y, Kunstein L, Bierwagen A, Nowotny B, Kabisch S, Groener JB, Fleitmann AK, Herder C, Pacini G, Strassburger K, Haring HU, Nawroth PP, Pfeiffer AFH, Burkart V, Mussig K, Roden M, Szendroedi J. An 8-week diet high in cereal fiber and coffee but free of red meat does not improve beta-cell function in patients with type 2 diabetes mellitus: a randomized controlled trial. Nutr Metab (Lond). 2018 Dec 29;15:90. doi: 10.1186/s12986-018-0324-5. eCollection 2018. |
| 26070589 | Derived | Ziegler D, Strom A, Nowotny B, Zahiragic L, Nowotny PJ, Carstensen-Kirberg M, Herder C, Roden M. Effect of Low-Energy Diets Differing in Fiber, Red Meat, and Coffee Intake on Cardiac Autonomic Function in Obese Individuals With Type 2 Diabetes. Diabetes Care. 2015 Sep;38(9):1750-7. doi: 10.2337/dc15-0466. Epub 2015 Jun 12. |
| 25425219 | Derived | Nowotny B, Zahiragic L, Bierwagen A, Kabisch S, Groener JB, Nowotny PJ, Fleitmann AK, Herder C, Pacini G, Erlund I, Landberg R, Haering HU, Pfeiffer AF, Nawroth PP, Roden M. Low-energy diets differing in fibre, red meat and coffee intake equally improve insulin sensitivity in type 2 diabetes: a randomised feasibility trial. Diabetologia. 2015 Feb;58(2):255-64. doi: 10.1007/s00125-014-3457-8. Epub 2014 Nov 26. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |