An observational study in Obesity and Gastric Bypass, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-03-03.
Sponsored by University of Alberta · Observational
Background: Gastric bypass is the most commonly performed type of bariatric (obesity) surgery, has dramatically increased in popularity and is now considered to be preferred treatments in severely obese patients that fail non-surgical therapy - particularly in patients with type 2 diabetes. Drug malabsorption is a potential concern post-gastric bypass because intestinal length is reduced.
Purpose: The purpose of this controlled, pharmacokinetic study is to determine whether the absorption of a single dose of metformin, the first line drug treatment in patients with type 2 diabetes, is significantly reduced after gastric bypass.
Methods: A single dose of standard release metformin 1000 mg will be administered to patients who have undergone gastric bypass and to patients who have not received surgery but are on the wait list (wait-listed controls). Blood sampling and urine sampling will occur in standardized fashion over the ensuing 24 hours to measure and compare the absorption of metformin between study arms. 34 patients total will be recruited.
Significance: Following completion of this study, we will better understand how gastric bypass affects metformin absorption. Ultimately, this information will help to ensure that this patient population is receiving optimal doses of this important drug treatment.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 34 is below the median of 132 across 1,338 observational studies indexed under Obesity.
Browse Obesity studies →University of Alberta is the lead sponsor of 819 studies on the registry; 168 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Post gastric bypass and obese controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients living within and around Edmonton that have been referred to the Alberta Health Services Weight Wise Program
Exclusion Criteria:
Any contraindications to metformin therapy such as:
age, BMI, gender matched
Area-under-the-curve of metformin absorption (0-infinity)
Time frame: cross-sectional
AUC (0-24h)
Time frame: cross-sectional
tmax
Time frame: cross-sectional
cmax
Time frame: cross-sectional
AUC glucose (0-8h)
Time frame: cross-sectional
bioavailability of metformin (urine metformin concentration from 0-infinity)
Time frame: cross-sectional
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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