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Procedure

Simvastatin - Obese for Obesity

Phase 4
Waitlist Available
Led By Jose S dos Santos, PhD
Research Sponsored by Natalia Valadares de Moraes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time 0 up to 24 hours after single dose carvedilol administration
Awards & highlights

Study Summary

This trial is investigating the effect of obesity and weight-loss surgery on how two drugs are metabolized and excreted.

Eligible Conditions
  • Obesity
  • Post-Gastric Bypass Surgery
  • Roux-en-Y Gastric Bypass

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~urine sampling collected from time 0 up to 8 hours after metoprolol administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and urine sampling collected from time 0 up to 8 hours after metoprolol administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic analysis of carvedilol
Pharmacokinetic analysis of simvastatin
Secondary outcome measures
CYP2D6 phenotyping using metoprolol as a probe drug
CYP3A4 phenotyping using midazolam as a probe drug
Genotyping the main SNPs on CYP2C9, CYP2D6, ABCB1 and SLCO1B1 genes
+2 more

Trial Design

6Treatment groups
Active Control
Group I: Simvastatin - ObeseActive Control6 Interventions
Adult patients (18-65 years old) with body mass index > 30 kg/mˆ2 treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis.
Group II: Simvastatin - Healthy volunteersActive Control5 Interventions
Adult patients (18-65 years old) with body mass index < 25 kg/mˆ2 treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis
Group III: Simvastatin - Post-RYGBActive Control6 Interventions
Adult patients (18-65 years old) previously submitted to RYGB surgery treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis.
Group IV: Carvedilol Study - Healthy volunteersActive Control5 Interventions
Adult patients (18-65 years old) with body mass index < 25 kg/mˆ2 treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis
Group V: Carvedilol study - ObeseActive Control6 Interventions
Adult patients (18-65 years old) with body mass index > 30 kg/mˆ2 treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis.
Group VI: Carvedilol - Post-RYGBActive Control6 Interventions
Adult patients (18-65 years old) previously submitted to RYGB surgery treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis.

Find a Location

Who is running the clinical trial?

University of Sao PauloOTHER
1,044 Previous Clinical Trials
254,657 Total Patients Enrolled
32 Trials studying Obesity
1,798 Patients Enrolled for Obesity
Natalia Valadares de MoraesLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Fundação de Amparo à Pesquisa do Estado de São PauloOTHER_GOV
453 Previous Clinical Trials
44,159 Total Patients Enrolled
24 Trials studying Obesity
1,538 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this medical experiment still available?

"This investigation is no longer seeking new patients. It was posted on June 1st 2019 and last updated February 3rd 2022. Those hoping to participate in similar studies may wish to investigate the 1020 obesity-related trials or 141 Roux-en-Y gastric bypass bariatric surgery investigations which are currently recruiting volunteers."

Answered by AI

How many individuals have been recruited to participate in this clinical trial?

"This medical trial has concluded recruiting and is no longer actively seeking participants. Initially posted on June 1st 2019, it was most recently edited on February 3rd 2022. For those looking for alternative studies, there are 1020 trials presently requiring people with obesity and 141 demanding volunteers to undergo Roux-en-Y gastric bypass bariatric surgery."

Answered by AI

Has the FDA authorized Roux-en-Y gastric bypass bariatric surgery?

"We assign a score of 3 to Roux-en-Y gastric bypass bariatric surgery due to the medical evidence that supports its approval."

Answered by AI

Am I qualified to participate in this experiment?

"Candidates accepted into this study must have a diagnosis of obesity and should be within the 18 to 65 year old range. The recruitment phase aims for 120 participants in total."

Answered by AI

Does this clinical study accept adult participants aged 25 and up?

"This clinical trial mandates patients to be aged 18-65. There are 233 trials available for participants younger than the age of consent, and 755 studies open to those who surpass 65 years old."

Answered by AI

What results are researchers aiming to observe with this experiment?

"The primary outcome of this carvedilol study is to conduct pharmacokinetic analysis on simvastatin over a 24 hour period. Secondary objectives include genotyping the essential SNPs found in CYP2C9, CYP2D6, ABCB1 and SLCO1B1 genes via RT-PCR, phenotyping for CYP3A4 utilising midazolam as a probe drug (determined through chromatographic analysis), and evaluating the CYP2D6 phenotype using metoprolol as an indicator substance (assessed by measuring urinary concentration ratio)."

Answered by AI

Does this clinical experiment represent a novel approach to treatment?

"Since 2005, Merck Sharp & Dohme LLC has been researching Roux-en-Y gastric bypass bariatric surgery and completed their first trial in the same year. This initial research involving 80 people led to its Phase 4 drug approval; presently, 141 active studies are being conducted across 798 cities and 44 countries."

Answered by AI

What is the common motivation for individuals to undergo Roux-en-Y gastric bypass bariatric surgery?

"Roux-en-Y gastric bypass bariatric surgery is the preferred preoperative sedation technique, but it can be equally effective for hypertensive disease, seizures, epileptic disorders and memory loss."

Answered by AI

Has Roux-en-Y gastric bypass bariatric surgery been tested experimentally prior to this?

"Currently, there are 141 live clinical trials for Roux-en-Y gastric bypass bariatric surgery with 26 of them in the advanced Phase 3. Although a number of these experiments have been founded in Porto Alegre, California, 2187 institutions worldwide are hosting studies related to this process."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
~21 spots leftby Apr 2025