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

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ClinicalTrials.gov Identifier: NCT01522157
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
Hans Guldbrand, Vårdcentralen Lyckorna

Tracking Information
First Submitted Date  ICMJE January 17, 2012
First Posted Date  ICMJE January 31, 2012
Last Update Posted Date December 2, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
  • P-glucose [ Time Frame: 6 months ]
    mmol/l
  • P-Triglycerides [ Time Frame: 6 months ]
    mmol/l
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01522157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
  • P-Cholesterol [ Time Frame: 6 months ]
    mmol/l
  • P-LDL-Cholesterol [ Time Frame: 6 months ]
    mmol/l
  • P-HDL-Cholesterol [ Time Frame: 6 months ]
    mmol/l
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
Official Title  ICMJE A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
Brief Summary

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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2012)
20
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes mellitus type 2

Exclusion Criteria:

  • Treatment with insulin or sulfonylurea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01522157
Other Study ID Numbers  ICMJE Dnr 2011/418-31
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hans Guldbrand, Vårdcentralen Lyckorna
Study Sponsor  ICMJE Vårdcentralen Lyckorna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fredrik H Nystrom, Professor Department of Endocrinology Linköping University Hospital
PRS Account Vårdcentralen Lyckorna
Verification Date November 2013

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