Type 2 DiabetesLAF26NCT01516320

Mechanisms of Diabetes Relapse After Bariatric Surgery

A study testing Roux-en-Y Gastric Bypass, Laparoscopic adjustable gastric banding and Vertical Sleeve Gastrectomy in people with Type 2 Diabetes, run by Blandine Laferrere at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Roux-en-Y Gastric Bypass, Laparoscopic adjustable gastric banding and Vertical Sleeve Gastrectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 13 May 2009to 1 Sep 2014
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
History of Type 2 Diabetes before surgery
35 < BMI < 50
Non-Smoker
Total Body Weight < 300 LBS
30<Age<60

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HbA1c < 9%
Resting Blood Pressure < 160/100 mmHg
Beta Blockers discontinued 2 weeks prior
Fasting Triglyceride Concentration < 600 mg/dl (patient can be on dyslipidemia medications)
Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok)

Who cannot join

Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
Currently pregnant or nursing.
Known cardiovascular disease
Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection

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HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment.
Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test.
Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, 10025

Other trials in United States

About this study

The objective of this study is to investigate the different mechanisms by which Gastric Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent weight loss and at after surgery in terms of gut hormones levels, insulin secretion and glucose control.

Read the detailed description

The mechanisms of type 2 diabetes (T2DM) remission after gastric bypass surgery (GBP) are unclear. The levels of the gut hormones incretins and their effect on insulin secretion, which is impaired in T2DM, markedly increase after GBP. The anatomical changes of GBP, rather than weight loss, seem to be responsible for the changes of incretins. The objective of this proposal is to investigate the different mechanisms by which GBP, laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly patients with T2DM after GBP, LAGB or VSG.

AIM 1: Will study the short term changes of incretins levels and effect in obese individuals with T2DM after GBP, LAGB or VSG, before and 1 month after GBP or before and after equivalent weight loss after LAGB or VSG.

AIM 2: Will study the long-term (12 and 24 months after surgery) changes in the incretin effect on insulin secretion, in patients with T2DM after GBP, LAGB or VSG.

AIM 3: Will study the changes of insulin secretion to IV glucose (AIRg) and insulin sensitivity (Si), measured by the minimal model, in patients with T2DM after GBP, VSG or LAGB, before and at 24 months after the surgery, at weight stability under condition of controlled diet.

Conditions: Type 2 Diabetes
Being tested: Roux-en-Y Gastric Bypass, Laparoscopic adjustable gastric banding, Vertical Sleeve Gastrectomy
Keywords: Type 2 Diabetes, Gastric Bypass, Laparoscopic Banding, Vertical Sleeve Gastrectomy
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roux-en-Y Gastric BypassProcedure or surgery
A surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach. The goal of the surgery is weight loss.
Laparoscopic adjustable gastric bandingProcedure or surgery
A surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch. The goal of the surgery is weight loss.
Vertical Sleeve GastrectomyProcedure or surgery
A surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch. The goal of the surgery is weight loss.

Study groups in NCT01516320
Study group	Role	What they receive
Gastric Bypass (GBP) Subjects	Experimental	Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity. Receives: Procedure: Roux-en-Y Gastric Bypass
Laparoscopic adjustable gastric banding (LAGB) Subjects	Active comparator	Subjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity. Receives: Procedure: Laparoscopic adjustable gastric banding
Vertical Sleeve Gastrectomy (VSG) Subjects	Active comparator	Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity. Receives: Procedure: Vertical Sleeve Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in insulin secretion between groups.
The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.
Measured: 0 - 48 months after surgery

Secondary outcomes (2)

Difference in Incretin hormone response between groups.
The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.
Measured: 0 - 48 months after surgery
Difference in Body composition between groups
The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.
Measured: 0 - 48 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 20091 Sep 2014

First posted24 Jan 2012 (estimated)
Study start13 May 2009
Primary completion1 Sep 2014
Study completion1 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01516320
Sponsor's protocol ID: AAAO1101
Other IDs: R01DK067561
Acronym: LAF26
Status last verified: Jan 2017
First submitted: 19 Jan 2012
Last updated: 1 Feb 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Diabetes Relapse After Bariatric Surgery
ClinicalTrials.gov ID: NCT01516320
Acronym / sponsor ID: LAF26 / AAAO1101
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Gastric Bypass, Laparoscopic Banding, Vertical Sleeve Gastrectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Blandine LaferrereUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 13 May 2009 (actual)
Primary completion: 1 Sep 2014 (actual)
Study completion: 1 Sep 2014 (actual)
First posted: 24 Jan 2012 (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.

Detailed description

AIM 2: Will study the long-term (12 and 24 months after surgery) changes in the incretin effect on insulin secretion, in patients with T2DM after GBP, LAGB or VSG.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Gastric Bypass (GBP) Subjects	Experimental	Procedure: Roux-en-Y Gastric BypassSubjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.
Laparoscopic adjustable gastric banding (LAGB) Subjects	Active comparator	Procedure: Laparoscopic adjustable gastric bandingSubjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.
Vertical Sleeve Gastrectomy (VSG) Subjects	Active comparator	Procedure: Vertical Sleeve GastrectomySubjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
History of Type 2 Diabetes before surgery
35 < BMI < 50
Non-Smoker
Total Body Weight < 300 LBS

Key exclusion criteria (9 listed)

Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
Currently pregnant or nursing.
Known cardiovascular disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Roux-en-Y Gastric BypassA surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach. The goal of the surgery is weight loss.	Procedure or surgery	Gastric Bypass (GBP) Subjects
Laparoscopic adjustable gastric bandingA surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch. The goal of the surgery is weight loss.	Procedure or surgery	Laparoscopic adjustable gastric banding (LAGB) Subjects
Vertical Sleeve GastrectomyA surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch. The goal of the surgery is weight loss.	Procedure or surgery	Vertical Sleeve Gastrectomy (VSG) Subjects

Primary outcome

Difference in insulin secretion between groups.
Time frame: 0 - 48 months after surgery
The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.

2 secondary outcomes

Difference in Incretin hormone response between groups.
Time frame: 0 - 48 months after surgery
Difference in Body composition between groups
Time frame: 0 - 48 months after surgery

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 1 Feb 2017.
New York Obesity Nutrition Research CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
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Type 2 Diabetes
Active, not recruiting
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Recruiting
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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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?

A study testing Roux-en-Y Gastric Bypass, Laparoscopic adjustable gastric banding and Vertical Sleeve Gastrectomy in people with Type 2 Diabetes, run by Blandine Laferrere 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 11 inclusion and 9 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 1 Feb 2017. 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 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?

Difference in insulin secretion between groups. (time frame: 0 - 48 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516320.

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 1 Feb 2017.