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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

Study Description
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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.


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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. P-glucose [ Time Frame: 6 months ]
    mmol/l

  2. P-Triglycerides [ Time Frame: 6 months ]
    mmol/l


Secondary Outcome Measures :
  1. P-Cholesterol [ Time Frame: 6 months ]
    mmol/l

  2. P-LDL-Cholesterol [ Time Frame: 6 months ]
    mmol/l

  3. P-HDL-Cholesterol [ Time Frame: 6 months ]
    mmol/l


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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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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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Hans Guldbrand, Principal Investigator, Vårdcentralen Lyckorna
ClinicalTrials.gov Identifier: NCT01522157     History of Changes
Other Study ID Numbers: Dnr 2011/418-31
First Posted: January 31, 2012    Key Record Dates
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