Objective: Favorable effects of the Dietary Approaches to Stop Hypertension (DASH) diet on glucose tolerance and lipid profiles in gestational diabetes. Study design: parallel randomized controlled clinical trial. 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. Population and sample size: 40 patients with GDM among pregnant women of eligible and referred to Naghavi clinic in Kashan, in the study was selected. Intervention: These patients were divided to either an intervention group (DASH diet) or control group (standard diet) groups. After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After 4 weeks of experiment, fasting blood samples were tested again. Start and End Date of Intervention: 4 weeks (April 17, 2012- May 17, 2012). Outcomes: Baseline serum total cholesterol, LDL-cholesterol, HDL-cholesterol and TG, plasma glucose, serum insulin, hs-CRP, calcium, iron, zinc, HOMA-IR score, plasma TAC (total antioxidant capacity) and total glutathione.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204065623N2
Registration date:2012-04-09, 1391/01/21
Registration timing:prospective
Last update:
Update count:1
Registration date
2012-04-09, 1391/01/21
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-04-17, 1391/01/29
Expected recruitment end date
2012-05-17, 1391/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the Dietary Approaches to Stop Hypertension (DASH) on glucose tolerance and lipid profiles in gestational diabetes
Public title
effect of Diet theraphy in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Postal code
Approval date
2011-08-09, 1390/05/18
Ethics committee reference number
9013
Health conditions studied
1
Description of health condition studied
Diabetes mellitus in pregnancy
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
TG
Timepoint
the first and end intervention
Method of measurement
Enzymatic
2
Description
Total cholesterol
Timepoint
the first and end intervention
Method of measurement
Enzymatic
3
Description
Total antioxidant
Timepoint
the first and end intervention
Method of measurement
Spectrophotometric
4
Description
Total glutathione
Timepoint
the first and end intervention
Method of measurement
Spectrophotometric
5
Description
Serum calcium
Timepoint
the first and end intervention
Method of measurement
Enzymatic
6
Description
Plasma gucose
Timepoint
the first and end intervention
Method of measurement
Enzymatic
7
Description
Seum insulin
Timepoint
the first and end intervention
Method of measurement
Elisa
8
Description
hs-CRP
Timepoint
the first and end intervention
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: DASH diet, 6 serving Vegetables, 6 serving frutits, rich in fiber, whole grains, daily for 4 weeks
Category
Other
2
Description
Control group: Standard diet, 4 serving Vegetables, 4 serving fruits, rich in protein, daily for 4 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi clinic Kashan
Full name of responsible person
Dr Mansooreh Samimi
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Ravandi ghotbe anenue
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_za@yahoo.comasemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_za@yahoo.comasemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)