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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Low-fat Diet; Dietary supplement: Low-carbohydrate Diet; Dietary supplement: Mediterranean Diet

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, S-59183
    • Department of Medical and Health Sciences, Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes mellitus type 2

Exclusion Criteria:

• Treatment with insulin or sulfonylurea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: All test patients; All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.	Dietary supplement: Low-fat Diet; Low-fat Diet is provided for a breakfast and a lunch.; Dietary supplement: Low-carbohydrate Diet; Low-carbohydrate Diet is provided for a breakfast and a lunch.; Dietary supplement: Mediterranean Diet; Mediterranean Diet is provided for a breakfast and a lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P-glucose	mmol/l	6 months
P-Triglycerides	mmol/l	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P-Cholesterol	mmol/l	6 months
P-LDL-Cholesterol	mmol/l	6 months
P-HDL-Cholesterol	mmol/l	6 months

Collaborators and Investigators

• Sponsor: Vårdcentralen Lyckorna
• Investigators: Principal Investigator: Fredrik H Nystrom, Professor, Department of Endocrinology Linköping University Hospital

Publications and helpful links

General Publications

• 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.0079324. eCollection 2013.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (ESTIMATE): January 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Diet; Type 2 diabetes mellitus; Postprandial; Low-carbohydrate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Dnr 2011/418-31