Alpha-lipoic acid supplementation effects on the lipid profile, antioxidant capacity and malondialdehyde in patients with gestational diabetes mellitus
Objectives: 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 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 12 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 glucose, hemoglobin A1c, insulin, lipid profile, antioxidant capacity and malodialdehyde will be measured at the beginning and at the end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012925949N4
Registration date:2017-02-02, 1395/11/14
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-02-02, 1395/11/14
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
2017-02-19, 1395/12/01
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
Alpha-lipoic acid supplementation effects on the lipid profile, antioxidant capacity and malondialdehyde in patients with gestational diabetes mellitus
Public title
Effects of alpha-lipoic acid supplementation in gestational diabetes mellitus
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 sq, Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2017-01-02, 1395/10/13
Ethics committee reference number
IR.ARAKMU.REC.1395.343
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 12 weeks of intervention
Method of measurement
Colorimetric
2
Description
Fasting insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA
3
Description
HbA1C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Chromatoghraphy
4
Description
HDL-C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Spectrophotometric
5
Description
LDL-C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Friedewald’s equation
6
Description
TG
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
7
Description
TC
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
8
Description
Malondialdehyde
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
9
Description
Antioxidant capacity
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric
Secondary outcomes
1
Description
BMI
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
Intervention groups
1
Description
Intervention group: One capsule alpha-lipoic acid (100 mg) per day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: One capsule placebo cellulose acetate (100 mg) per day for 12 weeks.