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

November 29, 2013 updated by: Hans Guldbrand, Vårdcentralen Lyckorna

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
mmol/l
6 months
P-Triglycerides
Time Frame: 6 months
mmol/l
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vårdcentralen Lyckorna

Investigators

  • Principal Investigator: Fredrik H Nystrom, Professor, Department of Endocrinology Linköping University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2011/418-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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