ObesityINOGMANCT01571180
Influence of Obesity and Gastric Bypass on Medication Absorption
An observational study of Obesity, run by KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have scheduled a gastric bypass
Who may be able to join
- Patients who have scheduled gastric bypass
- Use of at least one chronic drug (including contraception)
Who cannot join
- Patients who have undergone another form of bariatric surgery before RYGB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity
- Keywords
- Obesity, Gastric bypass, Medication, Medication counseling, Dietary pattern, Follow-up of patients
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass | Obese patients who have scheduled a gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
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.
Measured: one year
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ina Gesquiere, KU Leuven
- Investigators
- Ina Gesquiere, PhD Student, Principal investigator, Katholieke Universiteit Leuven - Centre for PharmacotherapyVeerle Foulon, Pharm PhD, Study director, Katholieke Universiteit Leuven - Centre for Pharmacotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571180
- Sponsor's protocol ID
- s53782
- Acronym
- INOGMA
- Status last verified
- May 2017
- First submitted
- 2 Apr 2012
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Obesity and Gastric Bypass on Medication Absorption: Prospective Follow-up of Patients
- ClinicalTrials.gov ID
- NCT01571180
- Acronym / sponsor ID
- INOGMA / s53782
- Conditions
- Obesity
- Keywords
- Obesity, Gastric bypass, Medication, Medication counseling, Dietary pattern, Follow-up of patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,…. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass | – | –Obese patients who have scheduled a gastric bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have scheduled a gastric bypass
Key inclusion criteria (2 listed)
- Patients who have scheduled gastric bypass
- Use of at least one chronic drug (including contraception)
Key exclusion criteria (1 listed)
- Patients who have undergone another form of bariatric surgery before RYGB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Changes in dietary pattern before and after RYGB
Time frame: one year
Medication counseling
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ina Gesquiere, PhD Student principal investigator
Katholieke Universiteit Leuven - Centre for Pharmacotherapy
Veerle Foulon, Pharm PhD study director
Katholieke Universiteit Leuven - Centre for Pharmacotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication use (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.