Investigating the effect of alpha lipoic acid supplementation on oxidative stress and inflammatory markers in type 2 diabetic patients

Phase 3

Recruiting

• Conditions: Type 2 diabetes mellitus; Type 2 diabetes mellitus.

• Registration Number: IRCT20180407039219N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Willingness to cooperate
Age between 40-60 years old
Body mass index (BMI) between 18.5 to 29.9
At least 2 years of diagnosed type 2 diabetes
Controlled diabetes (HbA1C < 7%)

Exclusion Criteria

Taking insulin
History of angina, myocardial infarction, and stroke, as well as other chronic diseases including liver disease, gastrointestinal disease, kidney disease, malignant disease, thyroid disease and other chronic and infectious diseases in the past year
Tobacco and alcohol consumption in the last three months
Changes in treatment protocols in the last three months
Taking any medicine other than metformin, glibenclamide, statin drugs, ACEI, ARB and doses less than 80 mg aspirin
Regular use of herbal Supplements containing antioxidants and omega-3 in the last three months (at least once a week)
Pregnancy and lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;Lipoprotein-associated phospholipase A2 distribution among lipoproteins. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;ICAM-1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;VCAM-1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;TNF-a. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;Interleukin 6. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;8-Isoprostane. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;OX-LDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;Apolipoprotein A1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.

Secondary Outcome Measures

Name	Time	Method
Glucose. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Photometric assay.;Insuline. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;Total cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic assay.;HDL Cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic assay.;LDL Cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Friedewald formula.;Triglyceride. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic assay.