Gymnema Sylvestre vs Berberine in Obesity Gene Expression of Adipokines
NCT ID: NCT06426966
Last Updated: 2024-05-23
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-02-01
2017-02-01
Brief Summary
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Detailed Description
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Patients We included 50 Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG(kilogram)/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose \< 126 mg/dL or glycated hemoglobin \< 6.5%). Key exclusion criteria included (i) pregnant patients, (ii) diabetics, and (iii) patients with allergic reaction to any components of the supplements. The first study group, group A (25 patients) was treated with GS at a dose of two 200 mg capsules before breakfast, while in the second group, group B (25 patients) were treated with BBR at dose of one 500 mg tablet three times a day before each meal. In both groups, the treatment lasted 3 months.
Trial procedures and outcomes Anthropometric, physiological, and biochemical parameters were measured in two sessions, before and after treatment. The anthropometric measurements were body weight, height, waist, and hip circumference, in addition to body analysis using the Inbody 770. As a physiological measure, only blood pressure was considered using WelchAllyn brand anomanometers with cuff for obese patients. Regarding biochemical parameters, fasting glucose, lipid profile (total cholesterol, triglycerides, HDL, LDL), basal insulin and HbA1c were measured. Adherence to treatment and the presence of adverse effects was recorded using a log that indicated the time at which the tablets were ingested and whether they had any adverse effects that day.
Additionally, whole blood samples were taken from 50 patients, 25 had received treatment with GS (group A) and 25 received treatment with BBR (group B). The extraction of tRNA(transfer ribonucleic acid) was carried out using the TRIzol®Reagent technique, which consists of a mixture of guanidine isocyanate and phenol-chloroform. Once the total RNA was isolated, it was suspended in RNase-free water to avoid possible degradation of the sample before proceeding with reverse transcription. The extraction and integrity of the tRNA was verified by means of agarose gel electrophoresis. The final purity of the samples was calculated based on the absorbance obtained with a measurement at 260-280. cDNA(complementary DNA) amplification was performed using the "First Strand cDNA transcription" synthesis kit for rtPCR from Roche. A real-time polymerase chain reaction (RT-PCR) procedure was performed to determine the relative expression of the mRNA(messenger ribonucleic acid) of the genes studied, using probes from the human transcriptome library (Human Universal Probe Library), a LightCycler nano thermocycler and a TaqMan type reaction mixture, all from the Roche Diagnostics brand (Roche Diagnostics GmbH(Gesellschaft mit beschränkter Haftung), Mannheim, Germany). The oligo sequences of the primers (sense and antisense) were designed with ProbeFinder software (Apelin, NM\_017413.4, F, 5´ gaa agt ggg gga tgg cta ag 3´, R, 5´ ccc acc cac tac cct ctt ct 3´, Omentin, NM\_017625.2, F, 5´ tga ggg tca ccg gat gta ac 3´, R, 5´ gga ctg gcc tct gga aag ta 3´, Resistin, NM\_001193374.1, F, 5´ cca ccg aga ggg atg aaa g 3´, R, 5´ ttc ttc cat gga gca cag g 3´ and Visfatin, NM\_005746.2, F, 5´ aag gga tgg aac tac att ctt gag 3´, R, 5´ ctg tgt ttt cca ccg tga ag 3'. The reaction mix was prepared according to the manufacturer's protocol. Each sample was analyzed in duplicate, and the data obtained were analyzed with the LightCycler nano software.
Statistical analysis The distribution of the quantitative data was performed by Shapiro Wilk. The comparison of frequencies was carried out with X2, while the comparison of basal means between groups was performed with Student's t-test. Final means were compared with Student's t-test when no statistical differences were found in basal comparison, while in the parameters with significant differences in the basal measurement, a covariate adjustment (repeated measures ANOVA) and the Bonferroni test were applied to compare the final means between groups. Self-controlled analysis was performed with paired t test. Analyses were performed with GraphPad Prism software, version 8.0.0 for Windows (GraphPad Software, San Diego, CA, USA), and SPSS software, version 19 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 19.0. Armonk, NY(New York), USA: IBM Corp). A value of p\<0.05 was considered as statistical significance.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gymnema sylvestre
Patients who present Obesity administrated with Gymnema sylvestre. At a dose of two 200 mg capsules before breakfast
Gymnema sylvestre
Gymnema sylvestre also known as "meshashringi", is a plant from central and southern India. The leaf extract has been used as a laxative, diuretic, and cough suppressant; Likewise, it has antimicrobial, antihypercholesterolemic, and hepatoprotective activities. It is associated with antioxidant properties . Its adjuvant effect has been reported in the therapy of type 2 diabetes, revealing how its active compounds can influence glucose regulation and improve insulin sensitivity.
Berberine
Patients who present Obesity administrated with Berberine 500 mg tablet three times a day before each meal
Berberine
Berberine is an alkaloid derived from plants native to China called Rhizoma coptidis, Cortex phellodendrine and Hydrastis canadensis. These plants are used in the treatment of infectious diarrhea, inflammation, DM2, non-alcoholic fatty liver disease, dyslipidemias, cardiovascular diseases, and obesity. They have been shown to improve insulin sensitivity and stimulate glucose uptake through the activation of AMP-activated protein kinase (AMPK)
Interventions
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Berberine
Berberine is an alkaloid derived from plants native to China called Rhizoma coptidis, Cortex phellodendrine and Hydrastis canadensis. These plants are used in the treatment of infectious diarrhea, inflammation, DM2, non-alcoholic fatty liver disease, dyslipidemias, cardiovascular diseases, and obesity. They have been shown to improve insulin sensitivity and stimulate glucose uptake through the activation of AMP-activated protein kinase (AMPK)
Gymnema sylvestre
Gymnema sylvestre also known as "meshashringi", is a plant from central and southern India. The leaf extract has been used as a laxative, diuretic, and cough suppressant; Likewise, it has antimicrobial, antihypercholesterolemic, and hepatoprotective activities. It is associated with antioxidant properties . Its adjuvant effect has been reported in the therapy of type 2 diabetes, revealing how its active compounds can influence glucose regulation and improve insulin sensitivity.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* diabetics,
* patients with allergic reaction to any components of the supplements
18 Years
60 Years
ALL
Yes
Sponsors
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Instituto Nacional de Pediatria
UNKNOWN
National Polytechnic Institute, Mexico
OTHER
Responsible Party
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Cindy Rodríguez Bandala
PhD
References
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Zhang X, Ha S, Lau HC, Yu J. Excess body weight: Novel insights into its roles in obesity comorbidities. Semin Cancer Biol. 2023 Jul;92:16-27. doi: 10.1016/j.semcancer.2023.03.008. Epub 2023 Mar 24.
Zwick RK, Guerrero-Juarez CF, Horsley V, Plikus MV. Anatomical, Physiological, and Functional Diversity of Adipose Tissue. Cell Metab. 2018 Jan 9;27(1):68-83. doi: 10.1016/j.cmet.2017.12.002.
Recinella L, Orlando G, Ferrante C, Chiavaroli A, Brunetti L, Leone S. Adipokines: New Potential Therapeutic Target for Obesity and Metabolic, Rheumatic, and Cardiovascular Diseases. Front Physiol. 2020 Oct 30;11:578966. doi: 10.3389/fphys.2020.578966. eCollection 2020.
Steppan CM, Bailey ST, Bhat S, Brown EJ, Banerjee RR, Wright CM, Patel HR, Ahima RS, Lazar MA. The hormone resistin links obesity to diabetes. Nature. 2001 Jan 18;409(6818):307-12. doi: 10.1038/35053000.
Revollo JR, Korner A, Mills KF, Satoh A, Wang T, Garten A, Dasgupta B, Sasaki Y, Wolberger C, Townsend RR, Milbrandt J, Kiess W, Imai S. Nampt/PBEF/Visfatin regulates insulin secretion in beta cells as a systemic NAD biosynthetic enzyme. Cell Metab. 2007 Nov;6(5):363-75. doi: 10.1016/j.cmet.2007.09.003.
Dakroub A, A Nasser S, Younis N, Bhagani H, Al-Dhaheri Y, Pintus G, Eid AA, El-Yazbi AF, Eid AH. Visfatin: A Possible Role in Cardiovasculo-Metabolic Disorders. Cells. 2020 Nov 9;9(11):2444. doi: 10.3390/cells9112444.
Ugur K, Erman F, Turkoglu S, Aydin Y, Aksoy A, Lale A, Karagoz ZK, Ugur I, Akkoc RF, Yalniz M. Asprosin, visfatin and subfatin as new biomarkers of obesity and metabolic syndrome. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):2124-2133. doi: 10.26355/eurrev_202203_28360.
Huang J, Kang S, Park SJ, Im DS. Apelin protects against liver X receptor-mediated steatosis through AMPK and PPARalpha in human and mouse hepatocytes. Cell Signal. 2017 Nov;39:84-94. doi: 10.1016/j.cellsig.2017.08.003. Epub 2017 Aug 15.
Li C, Cheng H, Adhikari BK, Wang S, Yang N, Liu W, Sun J, Wang Y. The Role of Apelin-APJ System in Diabetes and Obesity. Front Endocrinol (Lausanne). 2022 Mar 9;13:820002. doi: 10.3389/fendo.2022.820002. eCollection 2022.
Sperling M, Grzelak T, Pelczynska M, Bogdanski P, Formanowicz D, Czyzewska K. Association of Serum Omentin-1 Concentration with the Content of Adipose Tissue and Glucose Tolerance in Subjects with Central Obesity. Biomedicines. 2023 Jan 24;11(2):331. doi: 10.3390/biomedicines11020331.
Related Links
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World Health Organization: WHO.
Other Identifiers
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20170253
Identifier Type: OTHER
Identifier Source: secondary_id
ESM.CE-01/7-12-2015
Identifier Type: -
Identifier Source: org_study_id
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