Gastric Bypass SurgeryNCT01930448
Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1
An observational study of Gastric Bypass Surgery and Gastric Banding, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gastric Bypass Surgery, Gastric Banding, Type 2 Diabetes
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: severly obese patients with type 2 diabetes undergoing gastric bypass or gastric banding
Who may be able to join
- obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research Center
New York, New York, 10025
About this study
Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.
Read the detailed description
All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.
- Conditions
- Gastric Bypass Surgery, Gastric Banding, Type 2 Diabetes
- Keywords
- Bariatric, Gastric Bypass, Gastric Banding,, Type 2 Diabetes, Incretins, GLP-1, GIP, Insulin secretion, insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
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 |
|---|---|---|
| gastric bypass | Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery | |
| gastric banding | surgical group of obese patients with type 2 diabetes undergoing gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incretin Effect
Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)
Measured: Before surgery, 1, 12, and 24 months post
Secondary outcomes (1)
Change in Body Composition
Body composition measurements to determine body volume, size, and fat
Measured: Before surgery, 12, and 24 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2008
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: PI relocated to another Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Bypass SurgeryStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Blandine Laferrere, MD, Principal investigator, New York Obesity Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930448
- Sponsor's protocol ID
- 03-108
- Status last verified
- Sep 2015
- First submitted
- 20 Aug 2013
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1
- ClinicalTrials.gov ID
- NCT01930448
- Acronym / sponsor ID
- 03-108
- Conditions
- Gastric Bypass Surgery, Gastric Banding, Type 2 Diabetes
- Keywords
- Bariatric, Gastric Bypass, Gastric Banding,, Type 2 Diabetes, Incretins, GLP-1, GIP, Insulin secretion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI relocated to another Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Aug 2013 (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.
Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.
Detailed description
All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric bypass | – | –Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery |
| gastric banding | – | –surgical group of obese patients with type 2 diabetes undergoing gastric banding |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- severly obese patients with type 2 diabetes undergoing gastric bypass or gastric banding
Key inclusion criteria (1 listed)
- obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery
Key exclusion criteria (0 listed)
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
Change in Incretin Effect
Time frame: Before surgery, 1, 12, and 24 months post
Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)
1 secondary outcome
Change in Body Composition
Time frame: Before surgery, 12, and 24 months post
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
Blandine Laferrere, MD principal investigator
New York Obesity Nutrition Research Center
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 Gastric Bypass Surgery and Gastric Banding, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 0 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: withdrawn, as of the sponsor's last update on 11 Sep 2015. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Incretin Effect (time frame: Before surgery, 1, 12, and 24 months post). 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 11 Sep 2015.