Impaired Renal FunctionNCT01507350
Effects of Obesity Surgery on Renal Function
An observational study of Impaired Renal Function, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Increasing risk of impaired renal function as a result of obesity is well known. Early data has postulated that weight loss might improve kidney function, but the evidence is rather limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Impaired Renal Function
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to 1 Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria. 2. Patients with a GFR <60 mL/min/1.73 m2
Who may be able to join
- Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
- Patients with a GFR <60 mL/min/1.73 m2
Who cannot join
- Allergy to chromium
Trial locations and contacts
1 site in 1 country.
About this study
Increasing risk of impaired renal function as a result of obesity is well known. Early data has postulated that weight loss might improve kidney function, but the evidence is rather limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in Renal Disease (MDRD) equations, have all yield conflicting results after weight loss surgery.
The study aim to assess:
- use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in renal function before and after weight loss surgery.
- the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss surgery
- the differences in alterations in renal function dependent on the surgical procedures( gastric bypass, gastric band, sleeve gastrectomy).
- the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.
Read the detailed description
This is a prospective study on obese human subjects undergoing bariatric surgery. Forty-five patients due to undergo gastric bypass (n=15), gastric banding (n=15), and gastric sleeve surgery (n=15) will be recruited.
Subjects will be screened prior to entry into the study with full history, examination, routine bloods (FBC, U+E, liver function tests, and glucose).
- Blood samples and 24h urine specimens are taken at four time points: preoperatively as well 6 weeks, 6 and 12 months postoperatively.
- The following methods of GFR assessment will be executed the same time point: measurement of serum creatinine concentration, calculation of the abbreviated and extended MDRD formulae, CCG, creatinine clearance, serum Cystatin C concentration and the 51Chromium-EDTA clearance.
Inclusion criteria
- Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
- Patients with a GFR <60 mL/min/1.73
Exclusion criteria
- Allergy to chromium
- Conditions
- Impaired Renal Function
- Keywords
- obesity related glmerulopathy, 51 Cr-EDTA clearance, impaired renal function, gastric band, GFR measurement, gastric bypass, sleeve gastrectomy
- Medical subject headings
- Renal Insufficiency
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 |
|---|---|---|
| Obesity Surgery | Patients having gastric band, sleeve gastrectomy, and gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance
The outcome measure is reported as the number of participants who achieved a change in the glomerular renal function after weight loss surgery as measured by 51Cr-EDTA Clearance.
51Cr-EDTA GFR was ascertained using bolus injection of 1.46-2.66 MBq 51Cr-EDTA, with between 6 and 8 venous blood samples were collected at approximately 15, 30, 60, 90, 120, 180, 240, and 300 min to assess 51Cr-EDTA clearance. 51Cr-EDTA GFR was calculated using the Bi-exponential Fitting Method described in the British Nuclear Medicine Society guidelines. The prepared standard and patient samples were counted for 15 and 60 mins respectively using a Wallac 1470 Wizard Gamma Counter (Perkin Elmer Inc., Waltham, Massachusetts, USA). The measured GFR was scaled to BSA in order to maintain uniformity in comparison to reported eGFR.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJun 2011
- Primary completion1 Jun 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Renal FunctionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carel Le Roux, Imperial College London
- Investigators
- Carel W le Roux, MBChB, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507350
- Sponsor's protocol ID
- BSR
- Status last verified
- Oct 2020
- First submitted
- 6 Jan 2012
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chuah LL, Miras AD, Perry LM, Frankel AH, Towey DJ, Al-Mayahi Z, Svensson W, le Roux CW. Measurement of glomerular filtration rate in patients undergoing obesity surgery. BMC Nephrol. 2018 Dec 29;19(1):383. doi: 10.1186/s12882-018-1188-7.
PubMed 30594245
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Obesity Surgery on Renal Function
- ClinicalTrials.gov ID
- NCT01507350
- Acronym / sponsor ID
- BSR
- Conditions
- Impaired Renal Function
- Keywords
- obesity related glmerulopathy, 51 Cr-EDTA clearance, impaired renal function, gastric band, GFR measurement, gastric bypass, sleeve gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increasing risk of impaired renal function as a result of obesity is well known. Early data has postulated that weight loss might improve kidney function, but the evidence is rather limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in Renal Disease (MDRD) equations, have all yield conflicting results after weight loss surgery.
The study aim to assess:
- use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in renal function before and after weight loss surgery.
- the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss surgery
- the differences in alterations in renal function dependent on the surgical procedures( gastric bypass, gastric band, sleeve gastrectomy).
- the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.
Detailed description
This is a prospective study on obese human subjects undergoing bariatric surgery. Forty-five patients due to undergo gastric bypass (n=15), gastric banding (n=15), and gastric sleeve surgery (n=15) will be recruited.
Subjects will be screened prior to entry into the study with full history, examination, routine bloods (FBC, U+E, liver function tests, and glucose).
- Blood samples and 24h urine specimens are taken at four time points: preoperatively as well 6 weeks, 6 and 12 months postoperatively.
- The following methods of GFR assessment will be executed the same time point: measurement of serum creatinine concentration, calculation of the abbreviated and extended MDRD formulae, CCG, creatinine clearance, serum Cystatin C concentration and the 51Chromium-EDTA clearance.
Inclusion criteria
- Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
- Patients with a GFR <60 mL/min/1.73
Exclusion criteria
- Allergy to chromium
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obesity Surgery | – | –Patients having gastric band, sleeve gastrectomy, and gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria. 2. Patients with a GFR <60 mL/min/1.73 m2
Key inclusion criteria (2 listed)
- Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
- Patients with a GFR <60 mL/min/1.73 m2
Key exclusion criteria (1 listed)
- Allergy to chromium
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
Changes in Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance
Time frame: 12 months
The outcome measure is reported as the number of participants who achieved a change in the glomerular renal function after weight loss surgery as measured by 51Cr-EDTA Clearance. 51Cr-EDTA GFR was ascertained using bolus injection of 1.46-2.66 MBq 51Cr-EDTA, with between 6 and 8 venous blood samples were collected at approximately 15, 30, 60, 90, 120, 180, 240, and 300 min to assess 51Cr-EDTA clearance. 51Cr-EDTA GFR was calculated using the Bi-exponential Fitting Method described in the British Nuclear Medicine Society guidelines. The prepared standard and patient samples were counted for 15 and 60 mins respectively using a Wallac 1470 Wizard Gamma Counter (Perkin Elmer Inc., Waltham, Massachusetts, USA). The measured GFR was scaled to BSA in order to maintain uniformity in comparison to reported eGFR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30594245Chuah LL, Miras AD, Perry LM, Frankel AH, Towey DJ, Al-Mayahi Z, Svensson W, le Roux CW. Measurement of glomerular filtration rate in patients undergoing obesity surgery. BMC Nephrol. 2018 Dec 29;19(1):383. doi: 10.1186/s12882-018-1188-7.
- 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.
Carel W le Roux, MBChB, PhD principal investigator
Imperial College London
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 Impaired Renal Function, run by Imperial College London at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 19 Nov 2020. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507350, which also lists 1 linked publication.
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 19 Nov 2020.