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

Morphic Medical Inc.22 enrolled

Overview

The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Obesity

Interventions

GI LinerDEVICE

Medical device placed endoscopically in the duodenum, nutritional counseling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. Eduardo Guimaraes Hourneauz de Moura

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

% 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

Time frame: 12 months

Secondary Outcomes

HbA1c Values at 12 Months

Time frame: 12 months

Data from ClinicalTrials.gov

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