Impaired Renal Function
Conditions
Keywords
obesity related glmerulopathy, 51 Cr-EDTA clearance, impaired renal function, gastric band, GFR measurement, gastric bypass, sleeve gastrectomy
Brief 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. 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: 1. use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in renal function before and after weight loss surgery. 2. the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss surgery 3. the differences in alterations in renal function dependent on the surgical procedures( gastric bypass, gastric band, sleeve gastrectomy). 4. 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). 1. Blood samples and 24h urine specimens are taken at four time points: preoperatively as well 6 weeks, 6 and 12 months postoperatively. 2. 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 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 Exclusion criteria 1\. Allergy to chromium
Interventions
None listed
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 m2
Exclusion criteria
* Allergy to chromium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Obesity Surgery |
|---|---|
| Age, Continuous | 62.0 years |
| BMI (kg/m^2) | 45.5 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Obesity Surgery | Changes in Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance | 0 Participants |