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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hans Guldbrand, Vårdcentralen Lyckorna
ClinicalTrials.gov Identifier:
NCT01522157
First received: January 17, 2012
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Low-fat Diet
Dietary Supplement: Low-carbohydrate Diet
Dietary Supplement: Mediterranean Diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Vårdcentralen Lyckorna:

Primary Outcome Measures:
  • P-glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    mmol/l

  • P-Triglycerides [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    mmol/l


Secondary Outcome Measures:
  • P-Cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    mmol/l

  • P-LDL-Cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    mmol/l

  • P-HDL-Cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    mmol/l


Enrollment: 19
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus type 2

Exclusion Criteria:

  • Treatment with insulin or sulfonylurea
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01522157

Locations
Sweden
Department of Medical and Health Sciences, Linköping University
Linköping, Sweden, S-59183
Sponsors and Collaborators
Vårdcentralen Lyckorna
Investigators
Principal Investigator: Fredrik H Nystrom, Professor Department of Endocrinology Linköping University Hospital
  More Information

No publications provided by Vårdcentralen Lyckorna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans Guldbrand, Principal Investigator, Vårdcentralen Lyckorna
ClinicalTrials.gov Identifier: NCT01522157     History of Changes
Other Study ID Numbers: Dnr 2011/418-31
Study First Received: January 17, 2012
Last Updated: November 29, 2013
Health Authority: Sweden: Institutional Review Board

Keywords provided by Vårdcentralen Lyckorna:
Diet
Low-carbohydrate
Postprandial
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014