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

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: None (Open Label) 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:

MedlinePlus related topics: Body Weight Weight Control

U.S. FDA Resources

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

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:

de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvão Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Júnior 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.


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 (IPD) Sharing Statement:
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 August 17, 2017