Thymol on Netrin-1 on Obese Patients

Study Overview
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Brief Summary
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The prevalence of obesity in Mexico is 35.4%, and it is considered a risk factor for the development of diabetes, systemic arterial hypertension and dyslipidemia. Obesity due to the increased distribution and growth of adipose tissue creates a pro-inflammatory state induced by molecules secreted by the adipocytes themselves. Netrin-1 is a cell migration protein, which directs the recruitment, migration and entrapment of macrophages in different tissues, within adipose tissue the entrapment of macrophages induces the release of pro-inflammatory cytokines, which increase the secretion of pro-inflammatory adipokines. It has been found in high concentration in patients with obesity, insulin resistance and type 2 diabetes. Thymol is a phytopharmaceutical derived from oregano oil that has shown powerful anti-inflammatory and antioxidant effects through the stimulation of PPAR-gamma, adiponectin and inhibition of the NF-κB pathway mediated by the JNK pathway, pathways in which netrin-1 is involved in macrophage entrapment and recruitment.

Detailed Description
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Objective: To evaluate the effect of thymol administration on the serum concentration of netrin-1 in obese subjects. Material and methods: this is a randomized, double-blind, placebo-controlled clinical trial design. Inclusion criteria: - Subjects between 18 and 35 years old. - Subjects with BMI ≥ 30.0 and ≤35.0. - Subjects with systolic blood pressure less than 135 mmHg. - Subjects with diastolic blood pressure less than 85 mmHg. - Voluntary acceptance and signing of the informed consent. These patients will be randomly assigned to two groups, one will have the intervention with thymol 200 mg every 8 hours for 90 days while the other will have placebo with Mg 200 mg every 8 hours for 90 days. Statistical analysis: quantitative variables: means and standard deviation. Qualitative variables: frequencies and percentages. In the comparison according to the serum level of netrin-1 between the two groups after the intervention: t student for quantitative variables, Chi square for qualitative variables. Statistical significance p equal to or less than 0.05.

Official Title
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Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients

Conditions
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Inflammatory Response, Obesity

Intervention / Treatment
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* Drug: Thymol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between 18 and 35 years old. BMI ≥ 30.0 and ≤35.0 Systolic blood pressure less than 135 mmHg. Diastolic blood pressure less than 85 mmHg. Exclusion Criteria: Subjects who are known to have a diagnosis, receive treatment, or are observed with: Rheumatological and / or thyroid disease. Chronic kidney disease and / or CKD-EPI glomerular filtration rate less than 60 ml / min / 1.72m2. Innate alterations of metabolism. Elevation of transaminases 2 times higher than normal. Total cholesterol greater than 250 mg / dl. Triglycerides greater than 300 mg / dl. Subjects presenting with acute illness, hospitalization, or drug treatment presented in the last 12 weeks prior to the study selection visit. Subjects with symptoms consistent with the definition of a probable case of COVID-19, as well as any subject with a diagnosis of COVID-19. Subjects who have had blood transfusions in the last 3 months. Regular smokers. Pregnant or lactating women. Women with a desire for pregnancy or who do not have a double barrier or progestin-only contraceptive method.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Thymol | Drug: Thymol<br>* 200 mg each 8 hours for 90 days<br>|
| Placebo Comparator: Group B<br>Calcined magnesia | Drug: Thymol<br>* 200 mg each 8 hours for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Netrin-1 | Enzyme-Linked ImmunoSorbent Assay | Change from baseline netrin-1 at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 | Enzyme-Linked ImmunoSorbent Assay | Change from baseline IL-6 at 90 days | 
| Adiponectin | Enzyme-Linked ImmunoSorbent Assay | Change from baseline adiponectin at 90 days | 
| Ultrasensitive C-reactive protein | Enzyme-Linked ImmunoSorbent Assay | Change from baseline hs-PCR at 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Netrin-1, Thymol