Influence of Obesity and Gastric Bypass on Medication Absorption (INOGMA)

May 17, 2017 updated by: Ina Gesquiere, KU Leuven

Influence of Obesity and Gastric Bypass on Medication Absorption: Prospective Follow-up of Patients

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven - Centre for Pharmacotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have scheduled a gastric bypass

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gastric Bypass
Obese patients who have scheduled a gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication use
Time Frame: one year
Patients will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. A questionnaire will be used to examine which drugs patients use and to what level they are adherent to treatment recommendations.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in dietary pattern before and after RYGB
Time Frame: one year
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 changes of the composition of the meals before and after RYGB. The correlation between the dietary/total intake and clinical parameters will be investigated.
one year
Medication counseling
Time Frame: one year
Patients will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. A questionnaire will be used to examine what kind of information they received about medication use pre- and post-RYGB.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Ina Gesquiere, PhD Student, Katholieke Universiteit Leuven - Centre for Pharmacotherapy
  • Study Director: Veerle Foulon, Pharm PhD, Katholieke Universiteit Leuven - Centre for Pharmacotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s53782

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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