Obesity, Morbid / Valsartan · Observational Study

Bariatric Surgery and Pharmacokinetics of Valsartan

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered observational study investigating whether bariatric surgery (gastric bypass or sleeve gastrectomy) alters the pharmacokinetics of valsartan by measuring serum area-under-curve over one year post-operatively. No results are yet available in this registry record; the study is still recruiting.

What was studied

Observational. Obesity, Morbid; age from 18 Years; to 70 Years. Intervention: Valsartan. n = 12. 1 site: Norway.

Key findings

Safety

Small planned sample size limits statistical power for pharmacokinetic inference.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting observational study with small planned enrollment (12 participants) investigating pharmacokinetic changes; no results are posted in this registry record.

Study design

As stated by the source record.

MethodsCase Only model. Prospective time perspective. Primary outcome measure: Valsartan concentration in blood serum (area under curve (AUC)) (assessed at From baseline to 1 year postoperatively)

DesignObservational

PopulationObesity, Morbid; age from 18 Years; to 70 Years

Sample size12

InterventionValsartan

Setting1 site: Norway

Reported figures

Quoted from the source exactly as published.

Planned enrollment12

Primary outcome measureValsartan concentration in blood serum (area under curve [AUC]), from baseline to 1 year postoperatively

Study statusRecruiting

Caveats

No results reported in this registry record; study is active and recruiting.
Small planned sample size limits statistical power for pharmacokinetic inference.
Observational design without control group; causality and generalizability to non-surgical populations cannot be assessed.
Methods, analysis plan, and primary outcome timing details not fully specified in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational design without control group; pharmacokinetic mechanism study.

Directness

strong

Directly measures valsartan serum concentration (AUC) as primary outcome.

Consistency

insufficient

No results reported; cannot assess consistency with other evidence.

Risk of bias

insufficient

Registry record does not report methods, blinding, or analysis plan.

Sample adequacy

limited

Estimated enrollment only 12 participants; small sample for pharmacokinetic inference.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03535376). This is a study registration, not published results. Lead sponsor: Norwegian University of Science and Technology. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 12 participants (ESTIMATED). Conditions: Obesity, Morbid. Interventions: DRUG: Valsartan. Primary outcome measures: Valsartan concentration in blood serum (area under curve (AUC)) , From baseline to 1 year postoperatively. Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on valsartan are investigated.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Obesity, MorbidValsartanNorwegian University of Science and TechnologyNCT03535376