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OpenTrials
Completed

NCT Number: NCT00791128

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

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

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Eduardo Guimaraes Hourneauz de Moura

São Paulo, 05493900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GI Liner

Device

Medical device placed endoscopically in the duodenum, nutritional counseling

Other names: GI Endobarrier Liner

Primary outcomes

  1. % 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 outcomes

  1. HbA1c Values at 12 Months

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Morphic Medical Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 14, 2008
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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