Thymol on Netrin-1 on Obese Patients

June 17, 2022 updated by: Maria Guadalupe Ramos Zavala, Centro Universitario de Ciencias de la Salud, Mexico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: Change from baseline glucosa at 90 days
Colorimetry
Change from baseline glucosa at 90 days
Insulin Insulina
Time Frame: Change from baseline insulina at 90 days
Colorimetry
Change from baseline insulina at 90 days
HDL
Time Frame: Change from baseline HDL at 90 days
Colorimetry
Change from baseline HDL at 90 days
LDL
Time Frame: Change from baseline LDL at 90 days
Colorimetry
Change from baseline LDL at 90 days
% visceral fat
Time Frame: Change from baseline % visceral fat at 90 days
Bioelectrical impedance analysis
Change from baseline % visceral fat at 90 days
Abdominal Circumference
Time Frame: Change from baseline abdominal circumference at 90 days
Centimeters
Change from baseline abdominal circumference at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Investigators

  • Study Chair: Maria G Ramos-Zavala, PhD, Centro Universitario de Ciencias de la Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-01621
  • 20-131 (Registry Identifier: Research Coordination)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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