Inflammatory Response, Obesity
Conditions
Keywords
Netrin-1, Thymol
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.
Interventions
DRUGThymol
200 mg each 8 hours for 90 days
Sponsors
Centro Universitario de Ciencias de la Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Capsules with the same characteristics (smell, color, taste). Random assignment.
Intervention model description
Clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Netrin-1 | Change from baseline netrin-1 at 90 days | Enzyme-Linked ImmunoSorbent Assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| % visceral fat | Change from baseline % visceral fat at 90 days | Bioelectrical impedance analysis |
| Glucose | Change from baseline glucosa at 90 days | Colorimetry |
| Abdominal Circumference | Change from baseline abdominal circumference at 90 days | Centimeters |
| Insulin Insulina | Change from baseline insulina at 90 days | Colorimetry |
| HDL | Change from baseline HDL at 90 days | Colorimetry |
| LDL | Change from baseline LDL at 90 days | Colorimetry |
Countries
Mexico
Contacts
Primary ContactMaria G Ramos-Zavala, PhD
Backup ContactJesus J Garcia-Galindo, MD
Outcome results
None listed