Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional plan only | Active Comparator | Nutritional plan according to your caloric requirements for lifestyle |
|
| 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 |
|
| Berberine, nutritional plan and moderate exercise | Experimental | nutritional plan, moderate aerobic exercise and the phytopharmaceutical Berberine 500 mg every 8 hours for 3 months. |
|
| No intervention | No Intervention | patients who met the inclusion criteria but did not receive treatment or intervention, only somatometry and blood samples were taken. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | The weight will be taken on a scale calibrated in kilograms. | the first 3 months every 2 weeks, then every month thereafter until 6 months are completed |
| Body mass index | The body mass index was calculated by dividing the weight in kilograms by the square of the height in meters. |
Not provided
Inclusion Criteria:
• Patients with BMI ≥ 30kg/m2
Exclusion Criteria:
• Pregnancy patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nadia-Mabel PV PhD Nadia Mabel Pérez Vielma, PhD | 044-5520583053 | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28572744 | Result | 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. | |
| 22019891 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2015 |
Not provided
Phase three clinical trial with three intervention groups
Not provided
Not provided
Not provided
Not provided
| nutritional plan | Behavioral | nutritional plan according to your caloric requirements for lifestyle change and you will be scheduled biweekly for 3 months |
|
| controlled moderate aerobic exercise | Behavioral | controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week. |
|
| 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 | Instrument: Body composition analyzer (InBody770). • The measurement was expressed in Kg, with a precision of 0.1 kg. It was determined with the body analyzer, programmed with the required parameters (age, sex, height, among others). | 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 | It was defined as the distance between the vertex and the support plane.
| Height will be measured every two weeks for 3 months and then every month for 3 months to complete the 6 months follow-up. |
| 23876739 | 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. |
| 22952395 | Result | Sarjeant K, Stephens JM. Adipogenesis. Cold Spring Harb Perspect Biol. 2012 Sep 1;4(9):a008417. doi: 10.1101/cshperspect.a008417. |
| 28604342 | 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. |
| 29024553 | 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. |
| 12219872 | 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. |
| 24866313 | 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. |
| 25506234 | 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. |
| 18473870 | 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. |
| Nov 20, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2015 | Nov 20, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided