Thymol on Netrin-1 on Obese Patients

Phase 2

• Conditions: Inflammatory Response; Obesity
• Interventions: Drug: Thymol

• Registration Number: NCT05427721
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-06-11
• Study Start: 2022-04-01
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-17
• Last Update Submitted: 2022-06-17
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Thymol	Thymol
Group B	Thymol	Calcined magnesia

Primary Outcome Measures

Name	Time	Method
Netrin-1	Change from baseline netrin-1 at 90 days	Enzyme-Linked ImmunoSorbent Assay

Secondary Outcome Measures

Name	Time	Method
IL-6	Change from baseline IL-6 at 90 days	Enzyme-Linked ImmunoSorbent Assay
Adiponectin	Change from baseline adiponectin at 90 days	Enzyme-Linked ImmunoSorbent Assay
Ultrasensitive C-reactive protein	Change from baseline hs-PCR at 90 days	Enzyme-Linked ImmunoSorbent Assay

Trial Locations

Locations (1)

INTEC, CUCS, Universidad de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico