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

NCT ID: NCT01522157

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Diet Low-carbohydrate Postprandial Type 2 diabetes mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All test patients

All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.

Group Type ACTIVE_COMPARATOR

Low-fat Diet

Intervention Type DIETARY_SUPPLEMENT

Low-fat Diet is provided for a breakfast and a lunch.

Low-carbohydrate Diet

Intervention Type DIETARY_SUPPLEMENT

Low-carbohydrate Diet is provided for a breakfast and a lunch.

Mediterranean Diet

Intervention Type DIETARY_SUPPLEMENT

Mediterranean Diet is provided for a breakfast and a lunch.

Interventions

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Low-fat Diet

Low-fat Diet is provided for a breakfast and a lunch.

Intervention Type DIETARY_SUPPLEMENT

Low-carbohydrate Diet

Low-carbohydrate Diet is provided for a breakfast and a lunch.

Intervention Type DIETARY_SUPPLEMENT

Mediterranean Diet

Mediterranean Diet is provided for a breakfast and a lunch.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus type 2

Exclusion Criteria

* Treatment with insulin or sulfonylurea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vårdcentralen Lyckorna

OTHER

Sponsor Role lead

Responsible Party

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Hans Guldbrand

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fredrik H Nystrom, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology Linköping University Hospital

Locations

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Department of Medical and Health Sciences, Linköping University

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 24312178 (View on PubMed)

Other Identifiers

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Dnr 2011/418-31

Identifier Type: -

Identifier Source: org_study_id