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

Randomized Controlled Trial Evaluating the Effect of Rosmarinus Officinalis Extract on Metabolic, Hepatic, Renal, Inflammatory, and Oxidative Stress Biomarkers in Patients With Type 2 Diabetes.

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.

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 evaluates changes in metabolic parameters, including fasting serum glucose and glycated hemoglobin (HbA1c); oxidative stress and antioxidant biomarkers, including malondialdehyde (MDA), superoxide dismutase (SOD), and reduced glutathione (GSH); and inflammatory biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP).

Cytogenetic outcomes are assessed in exfoliated buccal epithelial cells using the buccal micronucleus cytome (BMCyt) assay. These outcomes include micronuclei and other nuclear abnormalities associated with genomic damage and cytotoxicity. Cytogenetic assessments are performed at baseline (Day 0), Month 1, and Month 3.

Selected inflammatory and cardiovascular biomarkers are assessed at baseline, Month 3, and Month 6. These include IL-6, TNF-α, CRP, and Troponin T, allowing evaluation of inflammatory and cardiovascular-related changes during the extended follow-up period.

Overall, the study aims to investigate the potential complementary effects of methanolic Rosmarinus officinalis extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.

Inclusion Criteria:

1. Confirmed diagnosis of T2DM
2. Older adults over the age of 18.
3. Signed Informed Consent (Annex 1)
4. Clinical stability or absence of acute complications associated with diabetes or another disease at the time of the study.
5. Absence of other associated diseases except Obesity and/or Hypertension
6. Glomerular filtration rate greater than or equal to 60ml/min/1.73m2 according to the CKD-EPI 2021 formula

Exclusion Criteria:

1. Allergy or hypersensitivity to any of the components of Rosemary.
2. Pregnant or breastfeeding women.
3. Patients who are taking other supplements or medications that may interfere with the study results. (antioxidants)

5. Patients who are participating in another clinical trial simultaneously.