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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ina Gesquiere, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01571180
First received: April 2, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Obesity and Gastric Bypass on Medication Absorption: Prospective Follow-up of Patients

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastric Bypass
Obese patients who have scheduled a gastric bypass

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who have scheduled a gastric bypass

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571180

Locations
Belgium
KU Leuven - Centre for Pharmacotherapy
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit 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
  More Information

No publications provided

Responsible Party: Ina Gesquiere, Principal Investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01571180     History of Changes
Other Study ID Numbers: s53782
Study First Received: April 2, 2012
Last Updated: May 29, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
Obesity
Gastric bypass
Medication
Medication counseling
Dietary pattern
Follow-up of patients

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014