Type 2 DiabetesPhase 2NCT00791128
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
A Phase 2 study testing GI Liner in people with Type 2 Diabetes and Obesity, run by Morphic Medical Inc. at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- GI Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 to 65
- BMI 40 to 60
- Type II Diabetes
- Candidates for bariatric surgery
Who cannot join
- Patients with
- hepatitis B or C
- gastroesophageal reflux disease (GERD)
- HIV Positive diagnosis
- pancreatitis
- conditions of gastrointestinal tract, such as ulcers or Crohn's
- an infection or who are H. Pylori positive
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dr. Eduardo Guimaraes Hourneauz de Moura
São Paulo, São Paulo, 05493900
About this study
Official title: A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Read the detailed description
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- GI Liner
- Keywords
- Type 2 Diabetes
- 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.
GI LinerDevice
Also called GI Endobarrier Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
| Study group | Role | What they receive |
|---|---|---|
| EndoBarrier GI Liner | Experimental | 22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period. Receives: Device: GI Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Excess Weight Loss (EWL)
Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight
% EWL = (baseline excess weight - weight loss) x 100
Measured: 12 months
Secondary outcomes (1)
HbA1c Values at 12 Months
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 posted14 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Guimaraes Hourneaux de Moura, MD, Principal investigator, Hospital das Clinicas, Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791128
- Sponsor's protocol ID
- 06-6
- Status last verified
- Apr 2017
- First submitted
- 12 Nov 2008
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.
PubMed 21932999
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)
- ClinicalTrials.gov ID
- NCT00791128
- Acronym / sponsor ID
- 06-6
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Detailed description
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoBarrier GI Liner | Experimental | Device: GI Liner22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65
- BMI 40 to 60
- Type II Diabetes
- Candidates for bariatric surgery
Key exclusion criteria (7 listed)
- Patients with
- hepatitis B or C
- gastroesophageal reflux disease (GERD)
- HIV Positive diagnosis
- 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 |
|---|---|---|
| GI LinerAlso: GI Endobarrier LinerMedical device placed endoscopically in the duodenum, nutritional counseling | Device | EndoBarrier GI Liner |
Primary outcome
% of Excess Weight Loss (EWL)
Time frame: 12 months
Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight % EWL = (baseline excess weight - weight loss) x 100
1 secondary outcome
HbA1c Values at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21932999de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.
- Individual participant dataSharing planned: Undecided
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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.
Eduardo Guimaraes Hourneaux de Moura, MD principal investigator
Hospital das Clinicas, Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GI Liner in people with Type 2 Diabetes and Obesity, run by Morphic Medical Inc. at 1 site in Brazil.
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 4 inclusion and 7 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 Jun 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
% of Excess Weight Loss (EWL) (time frame: 12 months). 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 NCT00791128, which also lists 1 linked publication.
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 Jun 2017.