Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426966
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-05-15
Brief Title:
Gymnema Sylvestre vs Berberine in Obesity Gene Expression of Adipokines
Sponsor:
National Polytechnic Institute Mexico
Organization:
National Polytechnic Institute Mexico
Study Overview
Official Title:
Comparative Efficacy of Gymnema Sylvestre vs Berberine in the Clinical Outcomes and Gene Expression of Adipokines in Patients With Exogenous Obesity
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GS VS BBR A
Brief Summary:
Obesity is a disease that affects a large part of the worlds population and is a risk factor for the development of metabolic cardiovascular oncological and neurodegenerative diseases Treatments with Gymnema Sylvestre GS and Berberine BBR have been studied in metabolic diseases such as obesity and type 2 diabetes mellitus DM2 and have gained importance in recent years however questions remain regarding their comparative effect on biochemical parameters body composition and gene expression of adipokines Methodology We carried out a comparative study in 50 adult Mexican patients with a diagnosis of Obesity Two groups of patients were formed A Treated with GS and B Treated with BBR Baseline and final measurements were determined 3 months after treatment Biochemical and body composition parameters were evaluated and the gene expression of Resistin Res Omentin Om Visfatin Vis and Apelin Ap was determined as well as safety parameters
Detailed Description:
Trial oversight A comparative descriptive observational longitudinal and prospective analysis study was carried out in the Comprehensive Obesity and Overweight Care Program at the Higher School of Medicine This study was carried out in full accordance with good clinical practice guidelines and the Declaration of Helsinki The study was registered with the Research and Ethics Committee of the Higher School of Medicine ESMCE-017-12-2015 All patients signed the informed consent and the information was protected through a confidentiality letter
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 KGkilogramM2 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 mgdL or glycated hemoglobin 65 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 tRNAtransfer ribonucleic acid was carried out using the TRIzolReagent 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 cDNAcomplementary 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 mRNAmessenger 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 GmbHGesellschaft mit beschränkter Haftung Mannheim Germany The oligo sequences of the primers sense and antisense were designed with ProbeFinder software Apelin NM_0174134 F 5 gaa agt ggg gga tgg cta ag 3 R 5 ccc acc cac tac cct ctt ct 3 Omentin NM_0176252 F 5 tga ggg tca ccg gat gta ac 3 R 5 gga ctg gcc tct gga aag ta 3 Resistin NM_0011933741 F 5 cca ccg aga ggg atg aaa g 3 R 5 ttc ttc cat gga gca cag g 3 and Visfatin NM_0057462 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 manufacturers 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 Students t-test Final means were compared with Students 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 800 for Windows GraphPad Software San Diego CA USA and SPSS software version 19 IBM Corp Released 2015 IBM SPSS Statistics for Windows Version 190 Armonk NYNew York USA IBM Corp A value of p005 was considered as statistical significance
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 KGkilogramM2 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 mgdL or glycated hemoglobin 65 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 tRNAtransfer ribonucleic acid was carried out using the TRIzolReagent 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 cDNAcomplementary 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 mRNAmessenger 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 GmbHGesellschaft mit beschränkter Haftung Mannheim Germany The oligo sequences of the primers sense and antisense were designed with ProbeFinder software Apelin NM_0174134 F 5 gaa agt ggg gga tgg cta ag 3 R 5 ccc acc cac tac cct ctt ct 3 Omentin NM_0176252 F 5 tga ggg tca ccg gat gta ac 3 R 5 gga ctg gcc tct gga aag ta 3 Resistin NM_0011933741 F 5 cca ccg aga ggg atg aaa g 3 R 5 ttc ttc cat gga gca cag g 3 and Visfatin NM_0057462 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 manufacturers 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 Students t-test Final means were compared with Students 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 800 for Windows GraphPad Software San Diego CA USA and SPSS software version 19 IBM Corp Released 2015 IBM SPSS Statistics for Windows Version 190 Armonk NYNew York USA IBM Corp A value of p005 was considered as statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20170253 | OTHER | Instituto Politécnico Nacional México | None |