Effect of Gastric Bypass on the Absorption of Metformin

Obesity Clinical Trial

— ABSORB-Met  

Official title:

Effect of Gastric Bypass on the Absorption of Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013051
• Other study ID #: RES0002122
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: March 2, 2011
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada:Health Canada has reviewed this study and approved off-label use of metformin to non-diabetic patients.
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Patients living within and around Edmonton that have been referred to the Alberta Health Services Weight Wise Program

Exclusion Criteria:

1. Undergone or undergoing revision of a previous bariatric procedure

2. Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting

3. Currently on metformin therapy

4. Any contraindications to metformin therapy such as:

1. allergy to the drug

2. chronic metabolic acidosis

3. history of lactic acidosis

4. liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal

5. congestive heart failure

6. renal failure (glomerular filtration rate < 60 ml/min)

7. alcoholism

8. acute illness

9. fatty liver disease

5. Pregnant or nursing

6. Not taking furosemide or nifedipine (both drugs may increase metformin absorption by 15-20%)the day of visit 2.

7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Bypass
• Obesity

Locations

Country	Name	City	State
Canada	University of Alberta Hospital Clinical Investigation Unity	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area-under-the-curve of metformin absorption (0-infinity)		cross-sectional	No
Secondary	AUC (0-24h)		cross-sectional	No
Secondary	tmax		cross-sectional	No
Secondary	cmax		cross-sectional	No
Secondary	AUC glucose (0-8h)		cross-sectional	No
Secondary	bioavailability of metformin (urine metformin concentration from 0-infinity)		cross-sectional	No