Objectives: The aim of this study is to determine the effects of alpha-lipoic acid (ALA) supplementation on serum levels of leptin, adiponectin 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. The endocrinologist, pharmacy and the participants will be blinded to the study interventions. Setting 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. 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: 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 measures (variables): Serum levels of leptin, adiponectin and the adiponectin-to-leptin ratio will be evaluated at the beginning and at the end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091225949N5
Registration date:2017-09-22, 1396/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-22, 1396/06/31
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
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2017-09-13, 1396/06/22
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of alpha-lipoic acid supplementation on serum levels of leptin, adiponectin and their ratio in women with gestational diabetes
Public title
Effects of alpha-lipoic acid supplementation in women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No history of GDM and 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 and smoking.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Postal code
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.ARAKMU.REC.1396.91
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
Fasting insulin
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
3
Description
Fasting leptin
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
4
Description
Fasting adiponectin
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
BMI
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
Hadiseh Asl Fallah
Street address
Shora Square, Imam Khomeini Street, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Ghazavi
Street address
Basij Square, Sardasht, Arak University of Medical Sciences, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak 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
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Khosrowbeygi
Position
PhD
Other areas of specialty/work
Street address
Basij Square, Sardasht, Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Arak