A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
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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: None (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 |
- 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
| 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diabetes mellitus type 2
Exclusion Criteria:
- Treatment with insulin or sulfonylurea
Contacts and Locations
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
| Sweden | |
| Department of Medical and Health Sciences, Linköping University | |
| Linköping, Sweden, S-59183 | |
| Principal Investigator: | Fredrik H Nystrom, Professor | Department of Endocrinology Linköping University Hospital |
More Information
Publications:
| Responsible Party: | Hans Guldbrand, Principal Investigator, Vårdcentralen Lyckorna |
| ClinicalTrials.gov Identifier: | NCT01522157 History of Changes |
| Other Study ID Numbers: |
Dnr 2011/418-31 |
| First Submitted: | January 17, 2012 |
| First Posted: | January 31, 2012 |
| Last Update Posted: | December 2, 2013 |
| Last Verified: | November 2013 |
Keywords provided by Hans Guldbrand, 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 |