Clinical trial NCT05427721: Thymol on Netrin-1 on Obese Patients
Official title: Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Inflammatory Response
Obesity
Keywords: Netrin-1
Thymol
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Netrin-1
timeFrame: Change from baseline netrin-1 at 90 days
Secondary outcomes:
measure: IL-6
timeFrame: Change from baseline IL-6 at 90 days
measure: Adiponectin
timeFrame: Change from baseline adiponectin at 90 days
measure: Ultrasensitive C-reactive protein
timeFrame: Change from baseline hs-PCR at 90 days
Other outcomes:
measure: Glucose
timeFrame: Change from baseline glucosa at 90 days
measure: Insulin Insulina
timeFrame: Change from baseline insulina at 90 days
measure: HDL
timeFrame: Change from baseline HDL at 90 days
measure: LDL
timeFrame: Change from baseline LDL at 90 days
measure: % visceral fat
timeFrame: Change from baseline % visceral fat at 90 days
measure: Abdominal Circumference
timeFrame: Change from baseline abdominal circumference at 90 days
Locations:
city: Guadalajara
country: Mexico
facility: INTEC, CUCS, Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Centro Universitario de Ciencias de la Salud, Mexico
name: Maria G Ramos-Zavala, PhD
role: STUDY_CHAIR
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