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

This study is currently recruiting participants.

Verified April 2012 by Katholieke Universiteit Leuven

Sponsor:

Information provided by (Responsible Party):

Ina Gesquiere, Katholieke Universiteit Leuven

ClinicalTrials.gov Identifier:

NCT01571180

First received: April 2, 2012

Last updated: April 19, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 2, 2012

Last Updated Date

April 19, 2012

Start Date ^ICMJE

April 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Medication use [ Time Frame: one year ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01571180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in dietary pattern before and after RYGB [ Time Frame: one year ] [ Designated as safety issue: No ]
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.
Medication counseling [ Time Frame: one year ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Influence of Obesity and Gastric Bypass on Medication Absorption

Official Title ^ICMJE

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

Brief Summary

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

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,…. 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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients who have scheduled a gastric bypass

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Gastric Bypass

Obese patients who have scheduled a gastric bypass

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ina Gesquiere, PhD Student	32 16 323447	ina.gesquiere@pharm.kuleuven.be
Contact: Veerle Foulon	32 16 323464	veerle.foulon@pharm.kuleuven.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01571180

Other Study ID Numbers ^ICMJE

s53782

Has Data Monitoring Committee

Yes

Responsible Party

Ina Gesquiere, Katholieke Universiteit Leuven

Study Sponsor ^ICMJE

Katholieke Universiteit Leuven

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Katholieke Universiteit Leuven

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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