Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine
NCT ID: NCT06703086
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-01-05
2020-02-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nutritional plan only
Nutritional plan according to your caloric requirements for lifestyle
nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
Nutritional plan and moderate aerobic exercise
nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week
nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
controlled moderate aerobic exercise
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, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months.
Berberine Hydrochloride group
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.
nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
controlled moderate aerobic exercise
controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
No intervention
patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken.
No interventions assigned to this group
Interventions
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Berberine Hydrochloride group
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.
nutritional plan
nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months
controlled moderate aerobic exercise
controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.
Eligibility Criteria
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Inclusion Criteria
* 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
* Diabetics patients
* Presenting any serious adverse effect
* Patients who decide to withdraw from the protocol
18 Years
ALL
Yes
Sponsors
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National Polytechnic Institute, Mexico
OTHER
Responsible Party
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Modesto Gómez López
Ph.D., Molecular Biologist,
Principal Investigators
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Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD
Role: STUDY_DIRECTOR
044-5520583053
References
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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.
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.
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.
Sarjeant K, Stephens JM. Adipogenesis. Cold Spring Harb Perspect Biol. 2012 Sep 1;4(9):a008417. doi: 10.1101/cshperspect.a008417.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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No.ESM.CE-01/7-12-2015
Identifier Type: -
Identifier Source: org_study_id
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