Obesity Clinical Trial - Thymol on Netrin-1 on Obese Patients

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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: 1. - Subjects between 18 and 35 years old. 2. - Subjects with BMI ≥ 30.0 and ≤35.0. 3. - Subjects with systolic blood pressure less than 135 mmHg. 4. - Subjects with diastolic blood pressure less than 85 mmHg. 5. - 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05427721
Study type	Interventional
Source	Centro Universitario de Ciencias de la Salud, Mexico
Contact	Maria G Ramos-Zavala, PhD
Phone	3339523367
Email	ramos.zavala.mg@gmail.com
Status	Recruiting
Phase	Phase 2
Start date	April 1, 2022
Completion date	December 30, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.