Obesity, Morbid / Losartan · Observational Study

Bariatric Surgery and Pharmacokinetics of Losartan

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 planned observational study investigating how bariatric surgery (gastric bypass and sleeve gastrectomy) alters losartan pharmacokinetics, measured by serum area under curve from baseline to 1 year postoperatively. No results have been reported in this registry record, and the study is currently recruiting.

What was studied

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

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

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

Plain-language summary

This is an active observational study investigating pharmacokinetic changes from bariatric surgery; no results are reported in the registry record.

Study design

As stated by the source record.

MethodsCase Only model. Prospective time perspective. Primary outcome measure: Losartan 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

InterventionLosartan

Setting1 site: Norway

Reported figures

Quoted from the source exactly as published.

Planned sample size12

Primary outcome measureLosartan concentration in blood serum (area under curve), baseline to 1 year postoperatively

Caveats

This is a registry record; no results are reported and the study is still recruiting.
Observational design without described control group or comparator arm.
Very small planned sample size (n=12) limits statistical power and generalizability.
No information on participant retention, follow-up completion, or analytical methods provided.

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 or randomization described.

Directness

strong

Directly measures losartan pharmacokinetics (AUC) in affected population post-surgery.

Consistency

insufficient

No results reported; consistency with other evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not report methods detail, blinding, or bias mitigation strategies.

Sample adequacy

limited

Planned enrollment 12 participants is a very 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 (NCT03519893). 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: Losartan. Primary outcome measures: Losartan 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 losartan 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, MorbidLosartanNorwegian University of Science and TechnologyNCT03519893