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The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01049321
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : January 14, 2010
Sponsor:
Collaborator:
Shahid Motahari Hospital of Fooladshahr, Isfahan Steel Company, Isfahan
Information provided by:
Isfahan University of Medical Sciences

Study Description
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Brief Summary:
The investigators are not aware of any study regarding the effect of DASH eating pattern on different cardiovascular risks among type 2 diabetic patients. The investigators assumed that DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetic Patients Dietary Supplement: DASH diet Dietary Supplement: a usual diabetic diet Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: DASH diet
DASH: Dietary approaches to stop hypertension eating plan
 Dietary Supplement: DASH diet
Other Name: Dietary aproaches to stop hypertension
Placebo Comparator: Diabetic diet
Diabetic diet: a usual diabetic diet
 Dietary Supplement: a usual diabetic diet


Outcome Measures
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Primary Outcome Measures :
  1. Cardio-metabolic risks [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Hepatic function [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   44 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having type 2 diabetes

Exclusion Criteria:

  • Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01049321


Locations
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Iran, Islamic Republic of
Shahid motahari hospital, Esfahan Esteel company, Iran
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Shahid Motahari Hospital of Fooladshahr, Isfahan Steel Company, Isfahan
Investigators
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Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Isfahan University of medical sciences, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01049321    
Other Study ID Numbers: DASH and cardiovascular risks
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: March 2008
Keywords provided by Isfahan University of Medical Sciences:
Dietary Approach to Stop Hypertension
weight
coagulation
DASH eating pattern.