Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine

NCT06703086 | Completed DMC

• 1 other identifier: No.ESM.CE-01/7-12-2015
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Overweight; Berberine

Keywords

Obesity; Overweight; Berberine

Outcome Measures

Primary Outcomes (3)

• To determine the effects of Berberine on the gene modulation of NLRP3, in peripheral blood of patients with exogenous obesity

  Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR

  From enrollment to the end of treatment at 3 months

• To determine the effects of Berberine on the gene modulation of IL-1β in peripheral blood of patients with exogenous obesity

  Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR

  "From enrollment to the end of treatment at 3 months

• To determine the effects of Berberine on the gene modulation of TNFα in peripheral blood of patients with exogenous obesity

  Extraction of total RNA by TRIzol®Reagent and Real-time polymerase chain reaction, qRT-PCR in peripheral blood

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (5)

• 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.

Study Arms (4)

Nutritional plan only

ACTIVE COMPARATOR

Nutritional plan according to your caloric requirements for lifestyle

Behavioral: nutritional plan

Nutritional plan and moderate aerobic exercise

ACTIVE COMPARATOR

nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week

Behavioral: nutritional plan; Behavioral: controlled moderate aerobic exercise

Berberine, nutritional plan and moderate exercise

EXPERIMENTAL

nutritional plan, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months.

Dietary Supplement: Berberine Hydrochloride group; Behavioral: nutritional plan; Behavioral: controlled moderate aerobic exercise

No intervention

NO INTERVENTION

patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken.

Interventions

Berberine Hydrochloride group DIETARY_SUPPLEMENT

The patient will be given a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will be taken 3 tablets ( 500 mg) every 8 hours for 3 months.

Berberine, nutritional plan and moderate exercise

nutritional plan BEHAVIORAL

nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months

Berberine, nutritional plan and moderate exercise; Nutritional plan and moderate aerobic exercise; Nutritional plan only

controlled moderate aerobic exercise BEHAVIORAL

controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.

Berberine, nutritional plan and moderate exercise; Nutritional plan and moderate aerobic exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead

Related Publications (10)

• 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.

  PMID: 28572744 RESULT

• 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.

  PMID: 22019891 RESULT

• 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.

  PMID: 23876739 RESULT

• Sarjeant K, Stephens JM. Adipogenesis. Cold Spring Harb Perspect Biol. 2012 Sep 1;4(9):a008417. doi: 10.1101/cshperspect.a008417.

  PMID: 22952395 RESULT

• 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.

  PMID: 28604342 RESULT

• 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.

  PMID: 29024553 RESULT

• 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.

  PMID: 12219872 RESULT

• 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.

  PMID: 24866313 RESULT

• 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.

  PMID: 25506234 RESULT

• 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.

  PMID: 18473870 RESULT

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD

  044-5520583053

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Molecular Biologist,

Model Details: Phase three clinical trial with three intervention groups

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: January 5, 2019
• Primary Completion: August 15, 2019
• Study Completion: February 15, 2020
• Last Updated: November 25, 2024

Record last verified: 2024-11