Effect of Rosmarinus Officinalis Extract on Oxidative Stress and Inflammatory Biomarkers in Patients With Type 2 Diabetes (T2DM)

Condition(s) studied

Investigational drug(s) / intervention(s)

Placebo: Inactive substance with no therapeutic effect.

Rosmarinus officinalis extract: Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks

Study summary

This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study investigates the potential complementary effects of methanolic rosemary extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.

Eligibility

Primary outcome measure(s)

• Change in levels of Glutathione (GSH) — Baseline (Day 0) and Month 3.
  Evaluation of reduced glutathione (GSH) concentration as an indicator of antioxidant status (µmol/L).
• Change in levels of glycated hemoglobin (HbA1c) — Baseline (Day 0) and Month 3.
  Change in glycated hemoglobin (HbA1c) (%).
• Change in serum levels of Malondialdehyde (MDA) — Baseline (Day 0), Month 1, Month 2, Month 3.
  Measurement of serum malondialdehyde concentration as a marker of lipid peroxidation and oxidative stress. Change in serum malondialdehyde (MDA) levels (nmol/mL).
• Change in antioxidant enzyme activity of Superoxide Dismutase (SOD) — Baseline (Day 0) and Month 3.
  Assessment of superoxide dismutase activity in serum samples. Change in superoxide dismutase (SOD) activity (U/mL).
• Change in the frequency of micronuclei and nuclear buds in buccal epithelial cells — Baseline (Day 0), Month 1 and Month 3.
  Change in the frequency of micronucleated cells and cells with nuclear buds in exfoliated buccal epithelial cells assessed using the buccal micronucleus cytome (BMCyt) assay. Results are expressed as the number of cells presenting micronuclei or nuclear buds per 2,000 cells evaluated.
• Change in the frequency of nuclear abnormalities in buccal epithelial cells — Baseline (Day 0), Month 1 and Month 3.
  Change in the frequency of nuclear abnormalities assessed using the BMCyt assay, including binucleated cells, condensed chromatin, karyorrhexis, pyknosis, and karyolysis. Results are expressed as the number of cells presenting each nuclear abnormality per 2,000 evaluated cells.
• Change in fasting plasma glucose (FPG) — Baseline (Day 0), Month 3 and Month 6.
  Change in fasting plasma glucose (mg/dL).

Trial sites (1)

Other trials for the same condition