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Completed

NCT Number: NCT01013051

Effect of Gastric Bypass on the Absorption of Metformin

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.

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Key information

Conditions

Obesity Body Weight Gastric Bypass Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta Hospital Clinical Investigation Unity

Edmonton, Alberta, T6G2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Undergone or undergoing revision of a previous bariatric procedure
  • Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting
  • Currently on metformin therapy
  • Any contraindications to metformin therapy such as:
  • allergy to the drug
  • chronic metabolic acidosis
  • history of lactic acidosis
  • liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal
  • congestive heart failure
  • renal failure (glomerular filtration rate < 60 ml/min)
  • alcoholism
  • acute illness
  • fatty liver disease
  • Pregnant or nursing
  • Not taking furosemide or nifedipine (both drugs may increase metformin absorption by 15-20%)the day of visit 2.
  • Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol

Treatment and study plan

Primary outcomes

  1. Area-under-the-curve of metformin absorption (0-infinity)

    Time frame: cross-sectional

Secondary outcomes

  1. AUC (0-24h)

    Time frame: cross-sectional

  2. tmax

    Time frame: cross-sectional

  3. cmax

    Time frame: cross-sectional

  4. AUC glucose (0-8h)

    Time frame: cross-sectional

  5. bioavailability of metformin (urine metformin concentration from 0-infinity)

    Time frame: cross-sectional

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Acronym: ABSORB-Met

Important dates

Study start
2009
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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