IRCT | 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

#	Registration date	Revision Id
2	2019-08-24, 1398/06/02	101416
1	2019-05-25, 1398/03/04	91288

Protocol summary

Study aim: 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).
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 randomization method. They will be matched in age and BMI.
Settings and conduct: 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.
Participants/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: 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.
Main outcome variables: on serum values of catalase, thiol groups, oxidative stress index and homeostasis model assessment of beta-cell function (HOMA-B)

General information

Reason for update
Acronym
IRCT registration information: 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
Registration date: 2019-05-25, 1398/03/04

Registrant information: Name

Masoome Mandani

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 26 3430 9249

Email address

m.mandani@arakmu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-08-31, 1398/06/09
Expected recruitment end date: 2020-02-29, 1398/12/10
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: 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

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 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
Age: From 18 years old to 40 years old
Gender: Female

Phase

2-3

Groups that have been masked

Participant
Care provider
Data analyser

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Participants, healthcare providers and outcome assessors are blinded.

Blinding (investigator's opinion)

Double blinded

Blinding description

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.

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

Arak University of Medical Sciences,Basij square,Sardasht,Arak

City

Arak

Province

Markazi

Postal code

3848176941
Approval date: 2019-03-07, 1397/12/16
Ethics committee reference number: IR.ARAKMU.REC.1397.242

Health conditions studied

1

Description of health condition studied: Gestational diabetes mellitus
ICD-10 code: O24.4
ICD-10 code description: Diabetes mellitus arising in pregnancy

Primary outcomes

1

Description: Fasting glucose
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Colorimetric

2

Description: Antioxidant capacity
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Colorimetric

3

Description: Total oxidant status
Timepoint: Before and after 8 weeks of intervention
Method of measurement: کالریمتری

4

Description: Stress oxidative index
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Formula

5

Description: Glutathione
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Spectrophotometric

6

Description: BMI
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Formula

7

Description: Catalas
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Spectrophotometric

8

Description: insulin
Timepoint: Before and after 8 weeks of intervention
Method of measurement: ELISA

9

Description: Malondialdehyde
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Colorimetric

10

Description: HOMA-B
Timepoint: Before and after 8 weeks of intervention
Method of measurement: formula

Secondary outcomes

1

Description: BMI
Timepoint: Before and after 8 weeks of intervention
Method of measurement: Formula

Intervention groups

1

Description: Intervention group: Intervention group: One capsule alpha-lipoic acid (300 mg) per day for 8 weeks
Category: Treatment - Drugs

2

Description: Control group: Control group: One capsule placebo cellulose acetate (300 mg) day for 8 weeks.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Kamali hospital

Full name of responsible person

Bita Badenoosh

Street address

Kamali hospital, Kamali street, Shohada square, Shahid Beheshti street, Karaj

City

Karaj

Province

Alborz

Postal code

3134877179

Phone

+98 26 3222 2021

Email

b_badehnoosh@yahoo.com

1

Sponsor: Name of organization / entity

Arak University of Medical Sciences

Full name of responsible person

Mohammad Arjomandzadegan

Street address

Arak University of Medical Sciences, Basij Square, Sardasht, Arak

City

Arak

Province

Markazi

Postal code

3848176941

Phone

+98 86 3417 3638

Email

Research@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

Masoome Mamdani

Position

student

Latest degree

Master

Other areas of specialty/work

Biochemistry

Street address

Arak University of Medical Sciences,School of Medicine, , Department of Biochemistry,Basij Square,Sardasht,Arak

City

Arak

Province

Markazi

Postal code

3848176941

Phone

+98 86 3417 3501

Email

masoomemandany@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Arak University of Medical Sciences

Full name of responsible person

Masoome Mandani

Position

student

Latest degree

Master

Other areas of specialty/work

Biochemistry

Street address

School of Medicine,Arak University of Medical Sciences, Department of Biochemistry ,Basij Square, Sardasht, Arak

City

Arak

Province

Markazi

Postal code

3848176941

Phone

+98 86 3417 3501

Email

masoomemandany@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Arak University of Medical Sciences

Full name of responsible person

Masoome Mandani

Position

Student

Latest degree

Master

Other areas of specialty/work

Biochemistry

Street address

Arak University of Medical Sciences,School of Medicine,Department of Biochemistry, Sardasht, Basij Square, Arak

City

Arak

Province

Markazi

Postal code

3848176941

Phone

+98 86 3417 3501

Email

masoomemandany@gmail.com

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 researches.
From where data/document is obtainable: Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir
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.
Comments: No comments

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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Protocol summary

General information

Primary outcomes

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Intervention groups

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Recruitment centers

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Sponsors / Funding sources

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Protocol summary

General information

Secondary Ids

Ethics committees

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Health conditions studied

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Primary outcomes

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Secondary outcomes

1

Intervention groups

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Recruitment centers

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Sponsors / Funding sources

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Person responsible for general inquiries

Person responsible for scientific inquiries

Person responsible for updating data

Sharing plan