- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01049321
The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients
January 13, 2010 updated by: Isfahan University of Medical Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Isfahan, Iran, Islamic Republic of
- Shahid motahari hospital, Esfahan Esteel company, Iran
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
44 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having type 2 diabetes
Exclusion Criteria:
- Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: DASH diet
DASH: Dietary approaches to stop hypertension eating plan
|
Other Names:
|
|
PLACEBO_COMPARATOR: Diabetic diet
Diabetic diet: a usual diabetic diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardio-metabolic risks
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hepatic function
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
January 13, 2010
First Submitted That Met QC Criteria
January 13, 2010
First Posted (ESTIMATE)
January 14, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 14, 2010
Last Update Submitted That Met QC Criteria
January 13, 2010
Last Verified
March 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- DASH and cardiovascular risks
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Purdue UniversityCompletedHypertension | DyslipidemiasUnited States