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Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
This study has been completed.
Sponsor:
GI Dynamics
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00791128
First received: November 12, 2008
Last updated: April 12, 2017
Last verified: April 2017
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Purpose
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
| Condition | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes Obesity | Device: GI Liner | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by GI Dynamics:
Primary Outcome Measures:
- % 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
Secondary Outcome Measures:
- HbA1c Values at 12 Months [ Time Frame: 12 months ]
| Enrollment: | 22 |
| Study Start Date: | October 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EndoBarrier GI Liner
22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period.
|
Device: GI Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
Other Name: GI Endobarrier Liner
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 to 65
- BMI 40 to 60
- Type II Diabetes
- Candidates for bariatric surgery
Exclusion Criteria:
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791128
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791128
Locations
| Brazil | |
| Dr. Eduardo Guimaraes Hourneauz de Moura | |
| Sao Paulo, SP, Brazil, 05493900 | |
Sponsors and Collaborators
GI Dynamics
Investigators
| Principal Investigator: | Eduardo Guimaraes Hourneaux de Moura, MD | Hospital das Clinicas, Sao Paulo |
More Information
Publications:
| Responsible Party: | GI Dynamics |
| ClinicalTrials.gov Identifier: | NCT00791128 History of Changes |
| Other Study ID Numbers: |
06-6 |
| Study First Received: | November 12, 2008 |
| Results First Received: | November 1, 2016 |
| Last Updated: | April 12, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by GI Dynamics:
|
Type 2 Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Weight Loss Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 26, 2017