Back to resultsThymol on Netrin-1 on Obese Patients
Primary Purpose
Inflammatory Response, Obesity
Status
Recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Thymol
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Response focused on measuring Netrin-1, Thymol
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.
Sites / Locations
- INTEC, CUCS, Universidad de GuadalajaraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
Thymol
Calcined magnesia
Outcomes
Primary Outcome Measures
Netrin-1
Enzyme-Linked ImmunoSorbent Assay
Secondary Outcome Measures
IL-6
Enzyme-Linked ImmunoSorbent Assay
Adiponectin
Enzyme-Linked ImmunoSorbent Assay
Ultrasensitive C-reactive protein
Enzyme-Linked ImmunoSorbent Assay
Full Information
NCT ID
NCT05427721
First Posted
June 11, 2021
Last Updated
June 17, 2022
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05427721
Brief Title
Thymol on Netrin-1 on Obese Patients
Official Title
Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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:
- Subjects between 18 and 35 years old.
- Subjects with BMI ≥ 30.0 and ≤35.0.
- Subjects with systolic blood pressure less than 135 mmHg.
- Subjects with diastolic blood pressure less than 85 mmHg.
- 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Response, Obesity
Keywords
Netrin-1, Thymol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Clinical trial
Masking
ParticipantInvestigator
Masking Description
Capsules with the same characteristics (smell, color, taste). Random assignment.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Thymol
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Calcined magnesia
Intervention Type
Drug
Intervention Name(s)
Thymol
Intervention Description
200 mg each 8 hours for 90 days
Primary Outcome Measure Information:
Title
Netrin-1
Description
Enzyme-Linked ImmunoSorbent Assay
Time Frame
Change from baseline netrin-1 at 90 days
Secondary Outcome Measure Information:
Title
IL-6
Description
Enzyme-Linked ImmunoSorbent Assay
Time Frame
Change from baseline IL-6 at 90 days
Title
Adiponectin
Description
Enzyme-Linked ImmunoSorbent Assay
Time Frame
Change from baseline adiponectin at 90 days
Title
Ultrasensitive C-reactive protein
Description
Enzyme-Linked ImmunoSorbent Assay
Time Frame
Change from baseline hs-PCR at 90 days
Other Pre-specified Outcome Measures:
Title
Glucose
Description
Colorimetry
Time Frame
Change from baseline glucosa at 90 days
Title
Insulin Insulina
Description
Colorimetry
Time Frame
Change from baseline insulina at 90 days
Title
HDL
Description
Colorimetry
Time Frame
Change from baseline HDL at 90 days
Title
LDL
Description
Colorimetry
Time Frame
Change from baseline LDL at 90 days
Title
% visceral fat
Description
Bioelectrical impedance analysis
Time Frame
Change from baseline % visceral fat at 90 days
Title
Abdominal Circumference
Description
Centimeters
Time Frame
Change from baseline abdominal circumference at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria G Ramos-Zavala, PhD
Phone
3339523367
Email
ramos.zavala.mg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus J Garcia-Galindo, MD
Phone
3325828575
Email
dr.jonathangarcia1418@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria G Ramos-Zavala, PhD
Organizational Affiliation
Centro Universitario de Ciencias de la Salud, Mexico
Official's Role
Study Chair
Facility Information:
Facility Name
INTEC, CUCS, Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
4430
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria G Ramos-Zavala, PhD
Phone
3339533367
Email
ramos.zavala.mg@gmail.com
First Name & Middle Initial & Last Name & Degree
Jesus J Garcia-Galindo, MD
Phone
3325828575
Email
dr.jonathangarcia1418@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Thymol on Netrin-1 on Obese Patients
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