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

Type 2 Diabetes Clinical Trial

— DDIET  

Official title:

Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409330
• Other study ID #: DDIET3521
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2023
• Source: German Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Exclusion Criteria:

• disease duration more than five years,

• age of > 69 years,

• body mass index of < 30 kg/m2,

• hemoglobin A1c < 5,5 % or > 9%

• if patient becomes insulin therapy

• if patient has exclusion criteria for coffee consumption

• if patient is non-compliant with study protocol

• if patient is pregnant

• if patient has acute infection

• if patient has anaemia

• if patient has malignancies

• if patient has autoimmune or immune compromising diseases including HIV/AIDS

• if patient has psychiatric diseases or addiction

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Germany	Charite, Department of Internal Medicine	Berlin
Germany	University Hospital, Department of Internal Medicine III	Dresden
Germany	German Diabetes Center	Duesseldorf	NRW
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

Sponsors (1)

Lead Sponsor	Collaborator
German Diabetes Center

Country where clinical trial is conducted

Germany, 

Outcome

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