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:
Vårdcentralen Lyckorna
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
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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: 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
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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 02, 2015