German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)

Conditions

Type 2 Diabetes

Keywords

insulin sensitivity, type 2 diabetes, diet intervention

Brief summary

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.

Detailed description

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

Pafili K, Zaharia OP, Strassburger K, Knebel B, Herder C, Huttasch M, Karusheva Y, Kabisch S, Strom A, Nowotny B, Szendroedi J, Roden M.

2025-03-061 citations

10.1016/j.clnu.2025.02.032

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.

Karusheva Y, Kunstein L, Bierwagen A, Nowotny B, Kabisch S, Groener JB, Fleitmann AK, Herder C, Pacini G, Strassburger K, Häring HU, Nawroth PP, Pfeiffer AFH, Burkart V, Müssig K, Roden M, Szendroedi J.

2018-12-293 citations

10.1186/s12986-018-0324-5

Lower Hepatic Insulin Sensitivity in a Family with a Recently Described Glucokinase Gene Variant

Kálmán Bódis, Oana‐Patricia Zaharia, Yanislava Karusheva, Pavel Bobrov, Daniel F. Markgraf et al. (12 authors)

Diabetes2018-06-221 citations

10.2337/db18-1509-p

Low-energy diets differing in fibre, red meat and coffee intake equally improve insulin sensitivity in type 2 diabetes: a randomised feasibility trial.

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.

2014-11-2636 citations

10.1007/s00125-014-3457-8

Interventions

DIETARY_SUPPLEMENTdiet intervention

8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

No

Inclusion criteria

* Type 2 diabetic patients * disease duration for five years or less, * age of 69 years or less, * body mass index of 30 kg/m2 or more, * hemoglobin A1c of 5,5 % to 9% * patient should be on standard diet or metformin +/- acarbose monotherapy * patient should be without

Exclusion criteria

for coffee consumption

Design outcomes

Primary

Measure	Time frame	Description
whole body insulin sensitivity	8 weeks	measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary

Measure	Time frame	Description
intramyocellular lipids	8 weeks	MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle
skeletal muscle mitochondrial function - insulin signaling	8 weeks	muscle biopsy for assessment of insulin signaling
hepatocellular lipids	8 weeks	MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)
total body fat	8 weeks	MRI measurement of the effects of 8-week diet intervention on total body fat
insulin secretion	8 weeks	measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test
pancreatic fat	8 weeks	MRI measurement of the effects of 8-week diet intervention on pancreatic fat
skeletal muscle mitochondrial function - phosphate-recovery time	8 weeks	skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS

Countries

Germany

Outcome results

None listed