Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of zinc supplementation on expressed levels of insulin receptor, PPAR-alpha and GLUT4 genes in newborns of women with gestational diabetes.
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Design
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Parallel double-blind randomized controlled clinical trial.
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Settings and conduct
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50 patients with GDM among pregnant women of eligible and referred to gynecology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria will be insulin-dependent diabetes, smoking and history of kidney stones.
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Intervention groups
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Patients will be assigned to receive either zinc supplements (intervention group: n=25) or placebo (control group: n=25).Although the duration of intervention was 6 weeks, all women were followed up until the delivery.
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Main outcome variables
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Outcomes: Blood samples from cord will be taken to quantify expressed levels of insulin receptor (primary outcome), PPAR-alpha and GLUT4 genes (secondary outcomes).
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:
IRCT201604195623N76
Registration date:
2016-05-01, 1395/02/12
Registration timing:
retrospective
Last update:
2019-09-26, 1398/07/04
Update count:
1
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Registration date
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2016-05-01, 1395/02/12
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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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2016-02-20, 1394/12/01
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Expected recruitment end date
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2016-03-20, 1395/01/01
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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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Clinical trial of the effect of zinc supplementation compared with the placebo on expressed levels of insulin receptor, PPAR-alpha and GLUT4 genes in newborns of women with gestational diabetes
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Public title
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Effect of supplementation in treatment of women with 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:
Patients with gestational diabetes aged 18 to 40 years
Exclusion criteria:
Insulin-dependent diabetes
Smoking
History of kidney stones
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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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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either supplements (n = 25) or placebo (n = 25). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology clinics affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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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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2016-03-09, 1394/12/19
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Ethics committee reference number
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IR.Kaums.REC.1394.163
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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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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Expressed levels of insulin receptor 1 gene
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Timepoint
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Dlivery time
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Method of measurement
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PCR
2
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Description
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Expressed levels of insulin receptor 2 gene
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Timepoint
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Dlivery time
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Method of measurement
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PCR
Secondary outcomes
1
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Description
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Gene expression of PPAR-alpha
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Timepoint
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Delivery time
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Method of measurement
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PCR
2
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Description
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Gene expression of GLUT4
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Timepoint
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Delivery time
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Method of measurement
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PCR
3
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Description
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Gene expression of TGFB
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Timepoint
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Delivery time
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Method of measurement
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PCR
Intervention groups
1
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Description
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Intervention group: Zinc supplements, 30 mg, daily, for 6 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule, daily for 6 weeks orally.
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Category
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Treatment - Drugs
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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Vice chancellor for research, 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