Effect of Gastric Bypass on the Absorption of Metformin (ABSORB-Met)
|ClinicalTrials.gov Identifier: NCT01013051|
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : March 3, 2011
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.
|Condition or disease|
|Obesity Gastric Bypass|
|Study Type :||Observational|
|Estimated Enrollment :||34 participants|
|Observational Model:||Case Control|
|Official Title:||Effect of Gastric Bypass on the Absorption of Metformin|
|Study Start Date :||September 2009|
|Study Completion Date :||December 2010|
|Post Gastric Bypass|
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013051
|University of Alberta Hospital Clinical Investigation Unity|
|Edmonton, Alberta, Canada, T6G2B7|
|Principal Investigator:||Raj Padwal, MD||University of Alberta|