Type 2 DiabetesPhase 4NCT01848795
EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients
A Phase 4 study testing EndoBarrier Gastrointestinal Liner and Easy life balloon in people with Type 2 Diabetes and Obesity, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 1 site in Italy.
Trial summary
Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient absorption or gut hormone secretion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- EndoBarrier Gastrointestinal Liner and Easy life balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to May 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Adults (18-60 year old)
- Type 2 Diabetes diagnosed less than 10 years ago
- Obesity (BMI > 30)
Who cannot join
- pregnancy
- inflammatory bowel disease
- peptic ulcer
- gastrointestinal disease preventing device positioning
- pancreatitis,
- coronary artery disease
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- symptomatic pulmonary disease
- infection at the time of device placement,
- high risk of gastrointestinal bleeding (coagulopathy, bleeding diathesis, anti-coagulant therapy, Non-Steroid Anti-Inflammatory Drugs)
- altered GI anatomy that could affect device placement
- contraindication of positioning of the devices as per technical description of the producer
- C-peptide negative diabetes
- failure to understand the study protocol or not willing to undergo planned follow-up
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ISMETT
Palermo, Italy, 90127
Anna Casu, MD, +390912192111, acasu@ismett.edu
Mario Traina, MD, +390912192111, mtraina@ismett.edu
About this study
Official title: Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.
Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in patients undergoing malabsorptive or mechanical procedures will clarify this matter. EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.
The present study hypothesis is that the bypass of the first portion of the intestine obtained with the EndoBarrier will be more effective in improving glucose metabolism than the reduction of food intake obtained with the intragastric balloon. Since similar weight loss is expected in the two groups, the study will aid in understanding the mechanisms behind the metabolic improvement seeing after intestine bypass.
Read the detailed description
Bariatric surgery is an effective therapy for obesity. Malabsorption-based surgical techniques (excluding the first part of the gastrointestinal tract from the alimentary circuit) are also effective in correcting T2D, even before any significant weight loss has occurred. Proposed mechanisms to explain this beneficial effect include caloric restriction, altered secretion of gut hormones due to duodenal exclusion or due to contact of undigested food with the jejunal mucosa, pancreatic islet hyperfunction, changes of intestinal flora, mucosal inflammation, and/or changes in the biliary acid re-circulation.
EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.
The present study is a prospective, randomized clinical trial. It will compare the metabolic compensation between patient treated with EndoBarrier and patient treated with Intragastric Balloon.
The aims will be: comparison of glycemic control as measured by hemoglobin A1c (HbA1c), change in oral hypoglycemic drug consumption and body loss from baseline and during follow up in the two groups; evaluation of mechanisms implicated in glycemic control by measuring basal and stimulated insular hormones, glucose levels and gastrointestinal hormones; creation of a bio-bank and dedicated database to collect biological samples for further future studies.
Obese adult T2D patients (BMI ≥ 30) with diabetes duration <10 years will be randomized to receive either EndoBarrier (n=45) or Intragastric Balloon (n=45). The devices will be implanted and kept in place for the first 12 months of study and then removed. Clinical and biochemical data will be collected every 3 months during the 12 months of implant and for the subsequent 12 months after removal.
Statistics describing variables at baseline, at subsequent visits and at the end of the study will be produced for both groups of patients. The Student's t-test will be used for a cross-sectional analysis while the mixed model system will be used for longitudinal observations. Multivariate analysis will also be applied to better characterize differences that may be seen between the two groups.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- EndoBarrier Gastrointestinal Liner, Easy life balloon
- Keywords
- Type 2 Diabetes, Obesity, gastrointestinal hormones, intestinal bypass, endoscopy
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrier Gastrointestinal LinerDevice
Also called produced by GI Dynamics
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
Easy life balloonDevice
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
| Study group | Role | What they receive |
|---|---|---|
| EndoBarrier Gastrointestinal Liner | Experimental | The treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up. Receives: Device: EndoBarrier Gastrointestinal Liner |
| Intragastric Balloon | Active comparator | The treatment in this arm is the endoscopic positioning of the intragastric balloon (Easy life balloon) as a comparator and follow up. Receives: Device: Easy life balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
measurement of diabetes metabolic control
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Investigators
- Anna Casu, MD, Principal investigator, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848795
- Sponsor's protocol ID
- IRRB/30/10
- Status last verified
- Mar 2015
- First submitted
- 3 May 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT01848795
- Acronym / sponsor ID
- IRRB/30/10
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Type 2 Diabetes, Obesity, gastrointestinal hormones, intestinal bypass, endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 May 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.
Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in patients undergoing malabsorptive or mechanical procedures will clarify this matter. EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.
The present study hypothesis is that the bypass of the first portion of the intestine obtained with the EndoBarrier will be more effective in improving glucose metabolism than the reduction of food intake obtained with the intragastric balloon. Since similar weight loss is expected in the two groups, the study will aid in understanding the mechanisms behind the metabolic improvement seeing after intestine bypass.
Detailed description
Bariatric surgery is an effective therapy for obesity. Malabsorption-based surgical techniques (excluding the first part of the gastrointestinal tract from the alimentary circuit) are also effective in correcting T2D, even before any significant weight loss has occurred. Proposed mechanisms to explain this beneficial effect include caloric restriction, altered secretion of gut hormones due to duodenal exclusion or due to contact of undigested food with the jejunal mucosa, pancreatic islet hyperfunction, changes of intestinal flora, mucosal inflammation, and/or changes in the biliary acid re-circulation.
EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.
The present study is a prospective, randomized clinical trial. It will compare the metabolic compensation between patient treated with EndoBarrier and patient treated with Intragastric Balloon.
The aims will be: comparison of glycemic control as measured by hemoglobin A1c (HbA1c), change in oral hypoglycemic drug consumption and body loss from baseline and during follow up in the two groups; evaluation of mechanisms implicated in glycemic control by measuring basal and stimulated insular hormones, glucose levels and gastrointestinal hormones; creation of a bio-bank and dedicated database to collect biological samples for further future studies.
Obese adult T2D patients (BMI ≥ 30) with diabetes duration <10 years will be randomized to receive either EndoBarrier (n=45) or Intragastric Balloon (n=45). The devices will be implanted and kept in place for the first 12 months of study and then removed. Clinical and biochemical data will be collected every 3 months during the 12 months of implant and for the subsequent 12 months after removal.
Statistics describing variables at baseline, at subsequent visits and at the end of the study will be produced for both groups of patients. The Student's t-test will be used for a cross-sectional analysis while the mixed model system will be used for longitudinal observations. Multivariate analysis will also be applied to better characterize differences that may be seen between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoBarrier Gastrointestinal Liner | Experimental | Device: EndoBarrier Gastrointestinal LinerThe treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up. |
| Intragastric Balloon | Active comparator | Device: Easy life balloonThe treatment in this arm is the endoscopic positioning of the intragastric balloon (Easy life balloon) as a comparator and follow up. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults (18-60 year old)
- Type 2 Diabetes diagnosed less than 10 years ago
- Obesity (BMI > 30)
Key exclusion criteria (13 listed)
- pregnancy
- inflammatory bowel disease
- peptic ulcer
- gastrointestinal disease preventing device positioning
- pancreatitis,
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 |
|---|---|---|
| EndoBarrier Gastrointestinal LinerAlso: produced by GI DynamicsEndoscopy placement of EndoBarrier, and clinical and biochemical follow up | Device | EndoBarrier Gastrointestinal Liner |
| Easy life balloonEndoscopy placement of EndoBarrier, and clinical and biochemical follow up | Device | Intragastric Balloon |
Primary outcome
Glycated hemoglobin
Time frame: 12 months
measurement of diabetes metabolic control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
Anna Casu, MD principal investigator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EndoBarrier Gastrointestinal Liner and Easy life balloon in people with Type 2 Diabetes and Obesity, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 1 site in Italy.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Mar 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Casu, MD (+390912192111, acasu@ismett.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 12 months). 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 24 Mar 2015.