Effect of Gastric Bypass on the Absorption of Metformin (ABSORB-Met)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effect of Gastric Bypass on the Absorption of Metformin|
- Area-under-the-curve of metformin absorption (0-infinity) [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
- AUC (0-24h) [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
- tmax [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
- cmax [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
- AUC glucose (0-8h) [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
- bioavailability of metformin (urine metformin concentration from 0-infinity) [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2010|
|Post Gastric Bypass|
age, BMI, gender matched
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013051
|University of Alberta Hospital Clinical Investigation Unity|
|Edmonton, Alberta, Canada, T6G2B7|
|Principal Investigator:||Raj Padwal, MD||University of Alberta|