Evaluation of the effect of metformin/alpha-lipoic acid combination in prediabetes

Evaluation of the effect of metformin/alpha-lipoic acid combination compared with metformin in the improvement of glycemic parameters, lipid profile, biomarkers of inflammation and oxidative stress in prediabetic patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240501061620N2

Enrollment

Registered

2025-02-26

Start date

2025-03-05

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Prediabetes. Abnormal glucose

Interventions

Intervention 1: Intervention group: This group will receive metformin tablet 1000 mg/day and alpha-lipoic acid capsule 600 mg/day for 8 weeks. Intervention 2: Control group: This group will receive m

Eligibility

Sex/Gender

All

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: Adults aged under 60 years old with BMI = 35 kg/m2 or FBS = 110 mg/dL or HbA1c = 6% or Individuals with prior gestational diabetes mellitus

Exclusion criteria

Exclusion criteria: Smoking, alcohol or other abused substances Suffering from advanced liver or kidney disease Taking drugs or supplements that affect blood sugar other than metformin High blood sugar due to corticosteroid use, cancer or pancreatic cyst Suffering from polycystic ovary syndrome Inflammation or infection Pregnancy and breastfeeding Sensitivity or intolerance to metformin and/or alpha-lipoic acid

Design outcomes

Primary

Measure	Time frame
Level of IL-6. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood sampling and serum isolation.;Level of MDA. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood sampling and serum isolation.;Level of fasting blood sugar (FBS). Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;HbA1C. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of total cholesterol. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of triglycerides. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of LDL. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of HDL. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Level of CRP. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.	—

Measure

Time frame

Level of IL-6. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood sampling and serum isolation.;Level of MDA. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood sampling and serum isolation.;Level of fasting blood sugar (FBS). Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;HbA1C. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of total cholesterol. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of triglycerides. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of LDL. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Serum level of HDL. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.;Level of CRP. Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: Blood test.

—

Secondary

Measure	Time frame
Body mass index (BMI). Timepoint: Before the intervention and the end of intervention (8 weeks after the start of intervention). Method of measurement: How to calculate BMI: Weight (kg) / height squared (m2).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahareh Hakiminia

Semnan University of Medical Sciences

baharehhakiminia@yahoo.com+98 23 3344 1740

Outcome results

None listed

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