A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522157
• Other study ID #: Dnr 2011/418-31
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: November 29, 2013
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: November 2013
• Source: Vårdcentralen Lyckorna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient.

The investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes mellitus type 2

Exclusion Criteria:

• Treatment with insulin or sulfonylurea

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Low-fat Diet
Low-fat Diet is provided for a breakfast and a lunch.
• Low-carbohydrate Diet
Low-carbohydrate Diet is provided for a breakfast and a lunch.
• Mediterranean Diet
Mediterranean Diet is provided for a breakfast and a lunch.

Locations

Country	Name	City	State
Sweden	Department of Medical and Health Sciences, Linköping University	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Vårdcentralen Lyckorna

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P-glucose	mmol/l	6 months	No
Primary	P-Triglycerides	mmol/l	6 months	No
Secondary	P-Cholesterol	mmol/l	6 months	No
Secondary	P-LDL-Cholesterol	mmol/l	6 months	No
Secondary	P-HDL-Cholesterol	mmol/l	6 months	No