A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01522157|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : December 2, 2013
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 or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Dietary Supplement: Low-fat Diet Dietary Supplement: Low-carbohydrate Diet Dietary Supplement: Mediterranean Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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.
- P-glucose [ Time Frame: 6 months ]mmol/l
- P-Triglycerides [ Time Frame: 6 months ]mmol/l
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522157
|Department of Medical and Health Sciences, Linköping University|
|Linköping, Sweden, S-59183|
|Principal Investigator:||Fredrik H Nystrom, Professor||Department of Endocrinology Linköping University Hospital|