The aim of this study is to determine the effects of alpha-lipoic acid (ALA) supplementation on the Liver and kidney function tests in women with gestational diabetes mellitus (GDM).
Design
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 random sampling. They will be matched in age and BMI.
Settings and conduct
The endocrinologist and the participants will be blinded to the study interventions. The aim and procedures of the study will be conveyed to the participants and written informed consent will be obtained from each of them.
Participants/Inclusion and exclusion criteria
Major Inclusion and Exclusion criteria: 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.
Intervention groups
One group will receive ALA (one 100 mg capsule for 8 weeks) and the other group will receive placebo capsule containing cellulose acetate with the same dosage and period
Main outcome variables
Serum levels of gamma-glutamyltransferase (GGT), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), urea and creatinine will be evaluated at the beginning and at the end of the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160111025949N6
Registration date:2018-01-02, 1396/10/12
Registration timing:registered_while_recruiting
Last update:2018-01-02, 1396/10/12
Update count:0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Ali Khosrowbeygi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3638
Email address
a.khosrowbeygi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-30, 1396/10/09
Expected recruitment end date
2018-02-24, 1396/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Alpha-lipoic acid supplementation on the Liver and kidney function tests in women with gestational diabetes
Public title
Effects of alpha-lipoic acid supplementation in gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of gestational diabetes mellitus
Not consumption of vitamin and mineral supplements during the last 6 months
Exclusion criteria:
Preterm delivery
Preeclampsia
The need for insulin or oral medication for lowering blood sugar during the intervention
Bed rest
Alcoholism
Smoking
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling using random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The endocrinologist and the participants will be blinded to the study interventions.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht, Basij square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.ARAKMU.REC.1396.216
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
Fasting glucose
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
2
Description
Fasting insulin
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
3
Description
HbA1C
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Chromatoghraphy
4
Description
Gamma-glutamyltransferase
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
5
Description
Alanine transaminase
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
6
Description
Aspartate transaminase
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
7
Description
Alkaline phosphatase
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
8
Description
Urea
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
9
Description
Creatinine
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Colorimetric
Secondary outcomes
1
Description
Body mass index
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: One capsule alpha-lipoic acid (100 mg) per day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: One capsule placebo cellulose acetate (100 mg) per day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Ali Khosrowbeygi
Street address
Imam Khomeini Avenue
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3277 4001
Email
a.khosrowbeygi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Muhammad Arjmandzadegan
Street address
Basij Square, Sardasht, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
pajoohesh@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Khosrowbeygi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Basij Square, Sardasht, Department of Biochemistry, School of Medicine, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
a.khosrowbeygi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Khosrowbeygi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Basij Square, Sardasht, Department of Biochemistry, School of Medicine, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
a.khosrowbeygi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Khosrowbeygi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Basij Square, Sardasht, Department of Biochemistry, School of Medicine, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
a.khosrowbeygi@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only results of main outcomes
When the data will become available and for how long
Six months after publishing of the results
To whom data/document is available
Only for academic staffs and universities researches
Under which criteria data/document could be used
Only for international and between universities researchs
From where data/document is obtainable
Ali Khosrowbeygi;
a.khosrowbeygi@arakmu.ac.ir; khosrowbeygi@yahoo.com
What processes are involved for a request to access data/document
1. Requesting a team work clinical trial via email
2. Approving the proposal
3. Registration of the trial