Obesity, MorbidNCT01913392
Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate
An observational study of Obesity, Morbid and Transplant; Failure, Kidney, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Transplant; Failure, Kidney
- What is being tested?
- laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jul 2013to May 2018
- 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: morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease
Who may be able to join
- adult (>18 years)
- stage IV and V chronic renal disease (glomerular filtration rate < 30 ml/min,
- body mass index (BMI) of greater than 40 kg/m2 or > 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes
Who cannot join
- medically unfit for surgical intervention
- previous gastric or intestinal surgery
- active gastric disease
- pregnancy or lactation
- known intolerance to tacrolimus or mycophenolic acid
- awaiting potential multi-organ transplantation
- active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Clinical Study of the Effect of Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, on the Pharmacokinetics of Immunosuppressive Drugs in the Morbidly Obese, Kidney Transplant Candidate
A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.
Read the detailed description
The remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, weight, BMI, abdominal circumference, blood pressure, Hba1c , average daily insulin requirements, lipid profile, TSH, 24h urine creatinine clearance and the SF-36 Quality of life questionnaire.
- Conditions
- Obesity, Morbid, Transplant; Failure, Kidney
- Being tested
- laparoscopic sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| morbidly obese, chronic renal disease | adult patients (> 18 years) who have stage 4 or 5 chronic renal disease (CrCl < 30 ml/min) who are being considered for possible future kidney transplantation. The study inclusion criteria are an indication for laparoscopic sleeve gastrectomy (BMI > 40 kg/m2, or BMI > 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes) Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative
Tacrolimus and Mycophenolate AUC 0-24h
Measured: pre-bariatric surgery and 1 year after surgery
degree of weight loss achieved after bariatric surgery in the chronic renal failure patient.
weight, BMI and abdominal circumference measures
Measured: baseline and every 3 months
Evaluate the change in general quality of life score, SF-36
comparison of the SF score between Baseline and month 3, Baseline and month 6 and Baseline and month 12
Measured: Baseline and 1 year after bariatric surgery
Secondary outcomes (3)
evaluate changes to residual renal function in the pre-dialysis renal transplant candidate
serum creatinine/ urea, sodium, potassium, magnesium, calcium, phosphate and bicarbonate pre surgery and month 12
Measured: at baseline versus month 12 post-bariatric surgery
evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus
concommitant medication records at baseline vs month 12
Measured: baseline and 12 month post-bariatric surgery
the incidence of complications post-bariatric surgery will be evaluated
non serious and serious adverse events collection at Baseline, month 6 and month 12
Measured: 1, 6 and 12 months post-bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study start18 Jul 2013
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian surgical research fund, Astellas Pharma Canada, Inc.
- Responsible party
- Principal investigator, Gabriel Chan, Md, Maisonneuve-Rosemont Hospital
- Investigators
- Gabriel Chan, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913392
- Sponsor's protocol ID
- 2014-530-13022
- Status last verified
- Nov 2019
- First submitted
- 30 Jul 2013
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Clinical Study of the Effect of Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, on the Pharmacokinetics of Immunosuppressive Drugs in the Morbidly Obese, Kidney Transplant Candidate
- ClinicalTrials.gov ID
- NCT01913392
- Acronym / sponsor ID
- 2014-530-13022
- Conditions
- Obesity, Morbid, Transplant; Failure, Kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Canadian surgical research fund, Astellas Pharma Canada, Inc.
- Study start
- 18 Jul 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 1 Aug 2013 (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.
A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.
Detailed description
The remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, weight, BMI, abdominal circumference, blood pressure, Hba1c , average daily insulin requirements, lipid profile, TSH, 24h urine creatinine clearance and the SF-36 Quality of life questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| morbidly obese, chronic renal disease | – | Procedure: laparoscopic sleeve gastrectomyadult patients (> 18 years) who have stage 4 or 5 chronic renal disease (CrCl < 30 ml/min) who are being considered for possible future kidney transplantation. The study inclusion criteria are an indication for laparoscopic sleeve gastrectomy (BMI > 40 kg/m2, or BMI > 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease
Key inclusion criteria (3 listed)
- adult (>18 years)
- stage IV and V chronic renal disease (glomerular filtration rate < 30 ml/min,
- body mass index (BMI) of greater than 40 kg/m2 or > 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes
Key exclusion criteria (7 listed)
- medically unfit for surgical intervention
- previous gastric or intestinal surgery
- active gastric disease
- pregnancy or lactation
- known intolerance to tacrolimus or mycophenolic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic sleeve gastrectomy | Procedure or surgery | morbidly obese, chronic renal disease |
Primary outcome
changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative
Time frame: pre-bariatric surgery and 1 year after surgery
Tacrolimus and Mycophenolate AUC 0-24h
degree of weight loss achieved after bariatric surgery in the chronic renal failure patient.
Time frame: baseline and every 3 months
weight, BMI and abdominal circumference measures
Evaluate the change in general quality of life score, SF-36
Time frame: Baseline and 1 year after bariatric surgery
comparison of the SF score between Baseline and month 3, Baseline and month 6 and Baseline and month 12
3 secondary outcomes
evaluate changes to residual renal function in the pre-dialysis renal transplant candidate
Time frame: at baseline versus month 12 post-bariatric surgery
evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus
Time frame: baseline and 12 month post-bariatric surgery
the incidence of complications post-bariatric surgery will be evaluated
Time frame: 1, 6 and 12 months post-bariatric surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Prospective Study of the Changes in Pharmacokinetics of Immunosuppressive Medications after Laparoscopic Sleeve GastrectomyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gabriel Chan, MD principal investigator
Maisonneuve-Rosemont Hospital
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, Morbid and Transplant; Failure, Kidney, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Dec 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative (time frame: pre-bariatric surgery and 1 year after surgery). The study lists 3 primary outcomes in all. 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 2 Dec 2019.