ObesityABSORB-MetNCT01013051
Effect of Gastric Bypass on the Absorption of Metformin
An observational study of Obesity and Gastric Bypass, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Gastric Bypass
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Post gastric bypass and obese controls 1. Male and Female 2. 18 - 60 years old 3. ≥ 3 months post-RYGB surgery or wait listed for bariatric surgery 4. Able to provide written informed consent.
Who may be able to join
- Patients living within and around Edmonton that have been referred to the Alberta Health Services Weight Wise Program
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta Hospital Clinical Investigation Unity
Edmonton, Alberta, T6G2B7
About this study
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.
Read more
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.
- Conditions
- Obesity, Gastric Bypass
- Keywords
- obesity, gastric bypass, metformin, pharmacokinetics, absorption
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post Gastric Bypass | Not described | |
| Obese Controls | age, BMI, gender matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-under-the-curve of metformin absorption (0-infinity)
Measured: cross-sectional
Secondary outcomes (5)
AUC (0-24h)
Measured: cross-sectional
tmax
Measured: cross-sectional
cmax
Measured: cross-sectional
AUC glucose (0-8h)
Measured: cross-sectional
bioavailability of metformin (urine metformin concentration from 0-infinity)
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startSep 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Raj Padwal, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013051
- Sponsor's protocol ID
- RES0002122
- Acronym
- ABSORB-Met
- Status last verified
- Mar 2011
- First submitted
- 12 Nov 2009
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Bypass on the Absorption of Metformin
- ClinicalTrials.gov ID
- NCT01013051
- Acronym / sponsor ID
- ABSORB-Met / RES0002122
- Conditions
- Obesity, Gastric Bypass
- Keywords
- obesity, gastric bypass, metformin, pharmacokinetics, absorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2009
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post Gastric Bypass | – | – |
| Obese Controls | – | –age, BMI, gender matched |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Post gastric bypass and obese controls 1. Male and Female 2. 18 - 60 years old 3. ≥ 3 months post-RYGB surgery or wait listed for bariatric surgery 4. Able to provide written informed consent.
Key inclusion criteria (1 listed)
- Patients living within and around Edmonton that have been referred to the Alberta Health Services Weight Wise Program
Key exclusion criteria (16 listed)
- 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:
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area-under-the-curve of metformin absorption (0-infinity)
Time frame: cross-sectional
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Padwal, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Gastric Bypass, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area-under-the-curve of metformin absorption (0-infinity) (time frame: cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011.