NCT01571180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

5.3 years

First QC Date

April 2, 2012

Last Update Submit

May 17, 2017

Conditions

Obesity

Keywords

ObesityGastric bypassMedicationMedication counselingDietary patternFollow-up of patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in dietary pattern before and after RYGB

    one year

  • Medication counseling

    one year

Study Arms (1)

Gastric Bypass

Obese patients who have scheduled a gastric bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have scheduled a gastric bypass

You may qualify if:

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

You may not qualify if:

  • Patients who have undergone another form of bariatric surgery before RYGB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven - Centre for Pharmacotherapy

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ina Gesquiere, PhD Student

    Katholieke Universiteit Leuven - Centre for Pharmacotherapy

    PRINCIPAL INVESTIGATOR

  • Veerle Foulon, Pharm PhD

    Katholieke Universiteit Leuven - Centre for Pharmacotherapy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

BE(1)