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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Low-fat Diet; Dietary Supplement: Low-carbohydrate Diet; Dietary Supplement: Mediterranean Diet

• Registration Number: NCT01522157
• Lead Sponsor: Vårdcentralen Lyckorna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-29
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Diabetes mellitus type 2

Exclusion Criteria

• Treatment with insulin or sulfonylurea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All test patients	Low-fat Diet	All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.
All test patients	Low-carbohydrate Diet	All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.
All test patients	Mediterranean Diet	All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.

Primary Outcome Measures

Name	Time	Method
P-glucose	6 months	mmol/l
P-Triglycerides	6 months	mmol/l

Secondary Outcome Measures

Name	Time	Method
P-Cholesterol	6 months	mmol/l
P-LDL-Cholesterol	6 months	mmol/l
P-HDL-Cholesterol	6 months	mmol/l

Trial Locations

Locations (1)

Department of Medical and Health Sciences, Linköping University; 🇸🇪 Linköping, Sweden