Influence of Obesity and Gastric Bypass on Medication Absorption

NCT ID: NCT01571180

Last Updated: 2017-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-09-30

Brief Summary

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Patients who have scheduled a gastric bypass (RYGB) in UZ Leuven, will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. The purpose of this study is to explore current practice regarding the use of medication and medication counseling after RYGB and to examine the changes in dietary pattern before and after RYGB.

Detailed Description

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Target group: patients who have scheduled a gastric bypass in UZ Leuven. Patients will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. Each assessment will be performed during a routine consultation.

The following aspects will be investigated:

* Medication The investigators have composed a questionnaire to examine which drugs the patients use, adherence, information received about medication and from whom,…
* Clinical parameters Every consultation, concentrations of hemoglobin, iron, hepcidin, vitamin B12,…. and a 24h urine collection to determine calcium excretion will be collected.
* Dietary intake The investigators will ask patients to keep a food record during two non-consecutive days preceding each consultation. In this food record patients have to note all consumed foods and beverages with the right/estimated amounts. This makes it possible to see the changes of the composition of the meals before and after RYGB.
* Body composition

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric Bypass

Obese patients who have scheduled a gastric bypass

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who have scheduled gastric bypass
* Use of at least one chronic drug (including contraception)

Exclusion Criteria

* Patients who have undergone another form of bariatric surgery before RYGB
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Ina Gesquiere

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ina Gesquiere, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Katholieke Universiteit Leuven - Centre for Pharmacotherapy

Veerle Foulon, Pharm PhD

Role: STUDY_DIRECTOR

Katholieke Universiteit Leuven - Centre for Pharmacotherapy

Locations

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KU Leuven - Centre for Pharmacotherapy

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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s53782

Identifier Type: -

Identifier Source: org_study_id

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