Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity
研究概览
简要总结
The patients will be invited to participate in a research study aimed at determining the Gene Modulation of NLRP3, IL-1β and TNFα in peripheral blood of patients with exogenous obesity treated with berberine.
详细描述
The study will take 6 months in total, in this study will participate patients with exogenous obesity, which is defined as an abnormal accumulation of fat that can be detrimental to health. After the evaluation it will be determined if you meet the section criteria to be able to participate in the study. The patients will be randomly assigned to a group which may be:
Group I. The investigator will give a nutritional plan according to your caloric requirements for lifestyle change and the patients will be scheduled biweekly for 3 months to assess your weight, height, body mass index and percentages of fat or muscle.
Group 2. The investigator will be given a nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
The patient will be given a lifestyle change plan in accordance with their nutritional requirements.
Group 3. The investigator will give a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will take 3 tablets every 8 hours for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients with BMI ≥ 30kg/m2
- •With risk factors for type 2 diabetes (history of diabetic parents or siblings, sedentary habits)
- •Fasting blood glucose ≤ 126 mg/dL or glycosylated hemoglobin < 6.5%
- •Controlled arterial hypertension
- •>18 years of age
- •Accept and sign the informed consent
排除标准
- •• Pregnancy patients
- •Diabetics patients
- •Presenting any serious adverse effect
- •Patients who decide to withdraw from the protocol
结局指标
主要结局
To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity
时间窗: From enrollment to the end of treatment at 3 months
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR
To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity
时间窗: "From enrollment to the end of treatment at 3 months
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR
To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity
时间窗: From enrollment to the end of treatment at 3 months
Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR in peripheral blood
次要结局
- Weight(the first 3 months every 2 weeks, then every month thereafter until 6 months are completed)
- Body mass index(Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.)
- Percentage of body fat(It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.)
- Percentage of visceral fat(To be taken every two weeks for the first 3 months and then every month for three months to complete 6 months of follow-up.)
- Height(Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up.)
研究者
Modesto Gómez López
Ph.D., Molecular Biologist,
National Polytechnic Institute, Mexico