Clinical trial NCT06703086: Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine
Official title: Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Berberine
Keywords: Obesity
Overweight
Berberine
Lead sponsor: National Polytechnic Institute, Mexico
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase three clinical trial with three intervention groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Biweekly sessions will be carried out for 3 months, then monthly for 6 months; blood samples will be taken at the beginning of the study, that is, after the informed consent, at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* • Pregnancy patients

  * Diabetics patients
  * Presenting any serious adverse effect
  * Patients who decide to withdraw from the protocol

Primary outcomes:
measure: To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity
timeFrame: From enrollment to the end of treatment at 3 months
measure: To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity
timeFrame: "From enrollment to the end of treatment at 3 months
measure: To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Weight
timeFrame: the first 3 months every 2 weeks, then every month thereafter until 6 months are completed
measure: Body mass index
timeFrame: Body mass index will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
measure: Percentage of body fat
timeFrame: It will be taken every two weeks for 3 months and then every month for 3 months to complete 6 months.
measure: Percentage of visceral fat
timeFrame: 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.
measure: Height
timeFrame: Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up.
Other outcomes:
Locations:
Study officials:
affiliation: 044-5520583053
name: Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD
role: STUDY_DIRECTOR
References:
citation: Chuang TY, Wu HL, Min J, Diamond M, Azziz R, Chen YH. Berberine regulates the protein expression of multiple tumorigenesis-related genes in hepatocellular carcinoma cell lines. Cancer Cell Int. 2017 May 30;17:59. doi: 10.1186/s12935-017-0429-3. eCollection 2017.
citation: Wei W, Zhao H, Wang A, Sui M, Liang K, Deng H, Ma Y, Zhang Y, Zhang H, Guan Y. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 2012 Jan;166(1):99-105. doi: 10.1530/EJE-11-0616. Epub 2011 Oct 21.
citation: Ali AT, Hochfeld WE, Myburgh R, Pepper MS. Adipocyte and adipogenesis. Eur J Cell Biol. 2013 Jun-Jul;92(6-7):229-36. doi: 10.1016/j.ejcb.2013.06.001. Epub 2013 Jun 14.
citation: Sarjeant K, Stephens JM. Adipogenesis. Cold Spring Harb Perspect Biol. 2012 Sep 1;4(9):a008417. doi: 10.1101/cshperspect.a008417.
citation: Merino M, Briones L, Palma V, Herlitz K, Escudero C. Role of adenosine receptors in the adipocyte-macrophage interaction during obesity. Endocrinol Diabetes Nutr. 2017 Jun-Jul;64(6):317-327. doi: 10.1016/j.endinu.2017.03.010. Epub 2017 May 16. English, Spanish.
citation: Fruh SM. Obesity: Risk factors, complications, and strategies for sustainable long-term weight management. J Am Assoc Nurse Pract. 2017 Oct;29(S1):S3-S14. doi: 10.1002/2327-6924.12510.
citation: Siani A, Cappuccio FP, Barba G, Trevisan M, Farinaro E, Lacone R, Russo O, Russo P, Mancini M, Strazzullo P. The relationship of waist circumference to blood pressure: the Olivetti Heart Study. Am J Hypertens. 2002 Sep;15(9):780-6. doi: 10.1016/s0895-7061(02)02976-x.
citation: Peralta-Romero Jde J, Gomez-Zamudio JH, Estrada-Velasco B, Karam-Araujo R, Cruz-Lopez M. [Genetics of pediatric obesity]. Rev Med Inst Mex Seguro Soc. 2014;52 Suppl 1:S78-87. Spanish.
citation: Al-Goblan AS, Al-Alfi MA, Khan MZ. Mechanism linking diabetes mellitus and obesity. Diabetes Metab Syndr Obes. 2014 Dec 4;7:587-91. doi: 10.2147/DMSO.S67400. eCollection 2014.
citation: Heilbronn LK, Campbell LV. Adipose tissue macrophages, low grade inflammation and insulin resistance in human obesity. Curr Pharm Des. 2008;14(12):1225-30. doi: 10.2174/138161208784246153.