Thymol Administration Effects on Netrin-1 Serum Concentration on Obese Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Netrin-1
研究概览
简要总结
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.
详细描述
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:
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- Subjects between 18 and 35 years old.
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- Subjects with BMI ≥ 30.0 and ≤35.0.
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- Subjects with systolic blood pressure less than 135 mmHg.
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- Subjects with diastolic blood pressure less than 85 mmHg.
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- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Capsules with the same characteristics (smell, color, taste). Random assignment.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 / 1.72m
- •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-
- •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.
研究组 & 干预措施
Group A
Thymol
干预措施: Thymol (Drug)
Group B
Calcined magnesia
干预措施: Thymol (Drug)
结局指标
主要结局
Netrin-1
时间窗: Change from baseline netrin-1 at 90 days
Enzyme-Linked ImmunoSorbent Assay
次要结局
- IL-6(Change from baseline IL-6 at 90 days)
- Adiponectin(Change from baseline adiponectin at 90 days)
- Ultrasensitive C-reactive protein(Change from baseline hs-PCR at 90 days)
研究者
Maria Guadalupe Ramos Zavala
Clinical Professor
Centro Universitario de Ciencias de la Salud, Mexico