Obesity, Morbid / Lamotrigine · Observational Study

Bariatric Surgery and Pharmacokinetics of Lamotrigine

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 examining how bariatric surgery (gastric bypass or sleeve gastrectomy) affects lamotrigine pharmacokinetics by measuring serum concentration over one year postoperatively. No results have been reported in this registry record; the study is currently recruiting.

What was studied

Observational. Obesity, Morbid; age from 18 Years; to 70 Years. Intervention: Lamotrigine. 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

If completed and results published, this study may clarify whether bariatric surgery alters lamotrigine bioavailability, with implications for seizure control or mood disorder treatment in patients undergoing these procedures. However, the small sample and observational design limit the strength of any future findings.

Plain-language summary

This is an ongoing observational study with very small planned enrollment (n=12) investigating pharmacokinetic changes; no results are yet reported in the registry record.

Study design

As stated by the source record.

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

InterventionLamotrigine

Setting1 site: Norway

Reported figures

Quoted from the source exactly as published.

Planned enrollment12

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

Study typeObservational

Follow-up duration1 year postoperatively

Clinical bottom line

Caveats

No results reported; this is a registry record only
Very small planned sample (n=12) limits statistical power and generalizability
Observational design without comparator or control group
No information on blinding, confounding adjustment, or analysis plan

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

Directness

strong

Directly measures lamotrigine serum concentration (AUC) in affected population

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record

Risk of bias

insufficient

Study is ongoing; methods for bias control not detailed in registry entry

Sample adequacy

limited

Only 12 participants estimated; 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 (NCT03497143). 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: Lamotrigine. Primary outcome measures: Lamotrigine 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 lamotrigine 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, MorbidNCT03497143LamotrigineNorwegian University of Science and Technology