Influence of Obesity and Gastric Bypass on Medication Absorption

Obesity Clinical Trial

— INOGMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01571180
• Other study ID #: s53782
• Status: Active, not recruiting
• Phase: N/A
• First received: April 2, 2012
• Last updated: May 17, 2017
• Start date: April 2012
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Belgium	KU Leuven - Centre for Pharmacotherapy	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication use	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	Changes in dietary pattern before and after RYGB	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
Secondary	Medication counseling	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