Inflammation Chronic, Oxidative Stress, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes Mellitus, Rosmarinus officinalis, Antioxidants, Rosemary Extract, inflammation, Randomized Controlled Trial
Brief 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.
Detailed description
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.
Interventions
OTHERPlacebo
Inactive substance with no therapeutic effect.
DIETARY_SUPPLEMENTRosmarinus officinalis extract
Methanolic extract of Rosmarinus officinalis administered orally for 12 weeks
Sponsors
Universidad Autonoma de Zacatecas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to treatment assignment. Both placebo (microcrystalline cellulose) and rosemary extract capsules are identical in appearance, packaging, and labeling, ensuring that participants cannot distinguish which intervention they receive.
Intervention model description
Two parallel groups of 20 participants each. One group receives 500 mg of placebo (microcrystalline cellulose) daily, and the other group receives 500 mg of methanolic rosemary extract daily. The intervention lasts for 12 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum levels of Interleukin-6 | Baseline (Day 0), Month 3, and Month 6. | Quantification of IL-6 levels using immunoassay techniques. Change in serum interleukin-6 (IL-6) levels (pg/mL). |
| Change in serum levels of Tumor Necrosis Factor Alpha | Baseline (Day 0), Month 3, and Month 6. | Evaluation of TNF-α as a marker of systemic inflammation. Change in serum tumor necrosis factor-alpha (TNF-α) levels (pg/mL). |
| Change in serum Troponin T levels | Baseline (Day 0), Month 3, and Month 6. | Change in serum Troponin T concentration as a biomarker of cardiovascular involvement. Troponin T will be measured using an enzyme immunoassay according to the manufacturer's instructions (pg/mL). |
| Change in levels of C-Reactive Protein (CRP) | Baseline (Day 0), Month 3, and Month 6. | Evaluation of CRP as a marker of systemic inflammation. Change in serum CRP levels (pg/mL). |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORDiana J Soriano Gálvez, M. en C.
Sin afiliación
PRINCIPAL_INVESTIGATORSandy F Rodriguez Reyes, Dr.
Sin afiliación
Outcome results
None listed