Protocol summary
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Study aim
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The aim of this study is to determine the effects of alpha-lipoic acid (ALA) supplementation on serum some biochemical variables in women with gestational diabetes mellitus (GDM).
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Design
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In this double blind study, a total number of 60 women with GDM will be selected. They will be divided into two groups of intervention (ALA) and control (placebo) by simple randomization method. They will be matched in age and BMI.
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Settings and conduct
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The aim and procedures of the study will be conveyed to the participants and written informed consent will be obtained from each of them. Patients were not aware of the type of drug and the statistician was not aware of the type of groups.
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Participants/Inclusion and exclusion criteria
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Major inclusion criteria are no history of GDM and not consumption of vitamin and mineral supplements during the last 6 months. Major Exclusion criteria are preterm delivery, preeclampsia, the need for insulin or oral medication for lowering blood sugar during the intervention and bed rest.
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Intervention groups
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Supplement group will receive ALA (daily 300 mg capsule for 8 weeks) and the control group will receive placebo capsule containing cellulose acetate with the same dosage and period.
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Main outcome variables
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on serum values of catalase, thiol groups, oxidative stress index and homeostasis model assessment of beta-cell function (HOMA-B)
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:
IRCT20181113041639N1
Registration date:
2019-05-25, 1398/03/04
Registration timing:
prospective
Last update:
2019-08-26, 1398/06/04
Update count:
1
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Registration date
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2019-05-25, 1398/03/04
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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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Expected recruitment start date
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2019-08-31, 1398/06/09
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Expected recruitment end date
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2020-02-29, 1398/12/10
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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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Alpha-lipoic acid supplementation effects on serum values of catalase, thiol groups, oxidative stress index and homeostasis model assessment of beta-cell function (HOMA-B) in women with gestational diabetes
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Public title
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Effects of alpha-lipoic acid supplementation in gestational diabetes mellitus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
No history of gestational diabetes mellitus
From 18 years old to 40 years old
No smoking
Exclusion criteria:
consumption of vitamin and mineral supplements during the last 6 months
Preterm delivery
Unwillingness to cooperate
Preeclampsia and other complications pregnancy during intervention
Thyroid disorders
Thalassemia
Severe anemia
Autoimmune diseases
Digestive diseases
Insulin therapy Oral glucose lowering drugs consumption
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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2-3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants, healthcare providers and outcome assessors are blinded.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, healthcare providers and outcome assessors are blinded.The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive. The statistician will not be informed about the grouping done.
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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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2019-03-07, 1397/12/16
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Ethics committee reference number
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IR.ARAKMU.REC.1397.242
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes mellitus
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ICD-10 code
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O24.4
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ICD-10 code description
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Diabetes mellitus arising in pregnancy
Primary outcomes
1
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Description
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Fasting glucose
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Colorimetric
2
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Description
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Antioxidant capacity
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Colorimetric
3
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Description
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Total oxidant status
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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کالریمتری
4
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Description
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Stress oxidative index
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Formula
5
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Description
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Glutathione
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Spectrophotometric
6
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Description
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BMI
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Formula
7
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Description
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Catalas
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Spectrophotometric
8
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Description
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insulin
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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ELISA
9
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Description
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Malondialdehyde
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Colorimetric
10
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Description
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HOMA-B
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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formula
Secondary outcomes
1
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Description
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BMI
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Timepoint
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Before and after 8 weeks of intervention
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Method of measurement
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Formula
Intervention groups
1
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Description
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Intervention group: Intervention group: One capsule alpha-lipoic acid (300 mg) per day for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Control group: One capsule placebo cellulose acetate (300 mg) day for 8 weeks.
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Category
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Placebo
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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Arak 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only results of main outcomes.
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When the data will become available and for how long
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Six months after publishing of the results.
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To whom data/document is available
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Only for academic staffs and universities researches.
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Under which criteria data/document could be used
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Only for international and between universities researches.
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From where data/document is obtainable
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Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir
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What processes are involved for a request to access data/document
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1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial.
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Comments
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No comments