Protocol summary
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Study aim
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Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes.
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Design
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Randomized clinical trial.
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Settings and conduct
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Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 78 patients will be selected according to inclusion and exclusion criteria. Fasting blood samples will be taken at baseline and 4 weeks after the intervention. At the beginning and the end of the intervention: 4 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation were included in this study. Elective subjects should not use replace treatments like Hormone or supplemental vitamin. Also those patients with preeclampsia and complete bed rest.
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Intervention groups
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Intervention: These patients were divided to 4 groups: intervention 1 (20 participants), control 1 (20 participants), intervention 2 (19 participants) and control 2 (19 participants).
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Main outcome variables
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Outcomes: Markers of HDL-cholesterol and hs-CRP (primary outcomes) and other lipid profiles and glycemic control (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201204065623N2
Registration date:
2012-04-09, 1391/01/21
Registration timing:
prospective
Last update:
2019-08-15, 1398/05/24
Update count:
1
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Registration date
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2012-04-09, 1391/01/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2012-04-17, 1391/01/29
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Expected recruitment end date
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2012-05-17, 1391/02/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of the Dietary Approaches to Stop Hypertension (DASH) on glucose tolerance and lipid profiles in gestational diabetes
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Public title
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effect of Diet theraphy in treatment of gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
Use replace treatments like hormone
Patients with preeclampsia
Complete bed rest
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
78
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be randomly allocated into two treatment groups to take either DASH or control diets. Randomization will be done by the use of computer software.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2011-08-09, 1390/05/18
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Ethics committee reference number
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9013
Health conditions studied
1
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Description of health condition studied
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Diabetes mellitus in pregnancy
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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Description
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HDL-cholesterol
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Timepoint
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The first and end intervention
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Method of measurement
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Enzymatic
2
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Description
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hs-CRP
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Timepoint
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The first and end intervention
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Method of measurement
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Elisa
Secondary outcomes
1
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 4 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
2
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 4 weeks of intervention
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Method of measurement
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Elisa kit
3
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 4 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 4 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 4 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 4 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: DASH diet, 6 serving Vegetables, 6 serving frutits, rich in fiber, whole grains, daily for 4 weeks
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Category
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Other
2
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Description
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Control group: Standard diet, 4 serving Vegetables, 4 serving fruits, rich in protein, daily for 4 weeks
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available