Trial Outcomes & Findings for Effects of Obesity Surgery on Renal Function (NCT NCT01507350)

Last Updated: 2020-11-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

9 participants

Primary outcome timeframe

12 months

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Obesity Surgery on Renal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obesity Surgery n=9 Participants 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.
Age, Continuous	62.0 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI (kg/m^2)	45.5 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Obesity Surgery n=9 Participants 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.
Changes in Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance	0 Participants

Adverse Events

Obesity Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carel le Roux

Imperial College

Phone: 07970719453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place