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

Investigate the effect of alpha lipoic acid supplementation on serum level of LP-PLA2, it`s distribution between HDL and apo B containing lipoproteins and related oxidative stress and inflammatory markers in type 2 diabetic patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180407039219N1
Enrollment
70
Registered
2018-04-27
Start date
2018-05-05
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: The patients in the intervention group will receive 1200 mg daily of alpha-lipoic acid supplements in the form of two 600 mg capsules and they will be asked to take

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Lipoprotein-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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Hosseini

Tehran University of Medical Sciences

Hosseinis@tums.ac.ir+98 21 8895 5569

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026