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IRCT20181113041639N1 IRCT 2019-05-25 Arak University of Medical Sciences Effects of alpha-lipoic acid supplementation in gestational diabetes mellitus 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 2019-08-31 anticipated 60 Complete https://irct.ir/trial/35331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants, healthcare providers and outcome assessors are 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. 2-3 Gestational diabetes mellitus. Intervention 1: Intervention group: Intervention group: One capsule alpha-lipoic acid (300 mg) per day for 8 weeks. Intervention 2: Control group: Control group: One capsule placebo cellulose acetate (300 mg) day for 8 weeks. Yes - There is a plan to make this available What will be shared: Only results of main outcomes. When: Six months after publishing of the results. To whom: Only for academic staffs and universities researches. Conditions: Only for international and between universities researches. Where to obtain: Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir How to obtain: 1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial. Comments: No comments
public Masoome Mamdani
Arak University of Medical Sciences,School of Medicine, , Department of Biochemistry,Basij Square,Sardasht,Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3501 masoomemandany@gmail.com Arak University of Medical Sciences scientific Masoome Mandani
School of Medicine,Arak University of Medical Sciences, Department of Biochemistry ,Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3501 masoomemandany@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) No history of gestational diabetes mellitus From 18 years old to 40 years old No smoking 18 years 40 years Female 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 O24.4 Diabetes mellitus arising in pregnancy Treatment - Drugs Placebo Intervention group: Intervention group: One capsule alpha-lipoic acid (300 mg) per day for 8 weeks Control group: Control group: One capsule placebo cellulose acetate (300 mg) day for 8 weeks. Fasting glucose. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Colorimetric. Antioxidant capacity. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Colorimetric. Total oxidant status. Timepoint: Before and after 8 weeks of intervention. Method of measurement: کالریمتری. Stress oxidative index. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Formula. Glutathione. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Spectrophotometric. BMI. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Formula. Catalas. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Spectrophotometric. Insulin. Timepoint: Before and after 8 weeks of intervention. Method of measurement: ELISA. Malondialdehyde. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Colorimetric. HOMA-B. Timepoint: Before and after 8 weeks of intervention. Method of measurement: formula. BMI. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Formula. Arak University of Medical Sciences Approved 2019-03-07 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences,Basij square,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)