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

January 17, 2012
November 29, 2013
January 2012
July 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01522157 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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.
Active Comparator: All test patients
All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.
Interventions:
  • Dietary Supplement: Low-fat Diet
  • Dietary Supplement: Low-carbohydrate Diet
  • Dietary Supplement: Mediterranean Diet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus type 2

Exclusion Criteria:

  • Treatment with insulin or sulfonylurea
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01522157
Dnr 2011/418-31
Not Provided
Hans Guldbrand, Vårdcentralen Lyckorna
Vårdcentralen Lyckorna
Not Provided
Principal Investigator: Fredrik H Nystrom, Professor Department of Endocrinology Linköping University Hospital
Vårdcentralen Lyckorna
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP