Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

NCT ID: NCT00791128

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

Conditions

Type 2 Diabetes; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GI Liner

Intervention Type: DEVICE

Medical device placed endoscopically in the duodenum, nutritional counseling

Interventions

GI Liner

Medical device placed endoscopically in the duodenum, nutritional counseling

Intervention Type: DEVICE

Other Intervention Names

GI Endobarrier Liner

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morphic Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Guimaraes Hourneaux de Moura, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas, Sao Paulo

Locations

Dr. Eduardo Guimaraes Hourneauz de Moura

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 21932999 (View on PubMed)

Other Identifiers

06-6

Identifier Type: -

Identifier Source: org_study_id