- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00830440
A Multicenter Study for Pre-Surgical Weight Loss
A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss
The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.
It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue.
The primary efficacy endpoint is:
- Assessment of the difference in % excess weight loss between the 2 groups
Secondary endpoints are:
- Resolution or Improvement in type II Diabetic status as defined as:
- Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
- Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
- The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands
- University Hospital Maastricht
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years and < 55 years - Male or Female
- BMI > 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or > 40 BMI <60 (with or without a co-morbid condition)
- History of failure with nonsurgical weight loss methods
- Candidates for Roux-en-Y gastric bypass
- Patients willing to comply with study requirements
- Patients who have signed an informed consent form
Exclusion Criteria:
- Patients requiring prescription anticoagulation therapy
- Patients with iron deficiency and iron deficiency anemia
- Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- Treatment represents an unreasonable risk to the patient
- Pancreatitis or other serious organic conditions
- Symptomatic coronary artery disease or pulmonary dysfunction
- Patients with known gallstones prior to implant
- Known infection at the time of implant
- Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- Pregnant or has the intention of becoming pregnant in the next 12 months
- Unresolved alcohol or drug addiction
- HIV Positive patients
- Patients with hepatitis B or C
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
- Previous GI surgery that could affect the ability to place the sleeve or the function of the implant.
- Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
- Patients receiving weight loss medications such as Meridia and Xenical
- Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Patients with gastroesophageal reflux disease (GERD)
- Patients with a history of kidney stones
- Participating in another ongoing investigational clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EndoBarrier Device
EndoBarrier Device and Diet & Lifestyle Counseling
|
NIH derived dietary, exercise and behavior modification 2005 guidelines.
https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks
Other Names:
NIH derived dietary, exercise and behavior modification 2005 guidelines.
https://health.gov/dietaryguidelines/2005.asp
|
ACTIVE_COMPARATOR: Control
Diet & Lifestyle Counseling
|
NIH derived dietary, exercise and behavior modification 2005 guidelines.
https://health.gov/dietaryguidelines/2005.asp
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Weight Change From Baseline at 12 Weeks in kg
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks
Time Frame: 12 weeks
|
The percent excess weight loss calculated using the Metropolitan Life Tables (MET).
The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.
|
12 weeks
|
Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12
Time Frame: Baseline to Week 12 of treatment
|
Baseline to Week 12 of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Willem Greve, MD, Maastricht University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on EndoBarrier Device
-
Maastricht University Medical CenterCompleted
-
GI DynamicsCompleted
-
GI DynamicsWithdrawn
-
GI DynamicsBiostatistical Consulting, Inc.Recruiting
-
University Hospital, LilleMinistry of Health, FranceTerminated
-
GI DynamicsCompletedObesity | Type 2 DiabetesUnited Kingdom
-
GI DynamicsCompletedType II DiabetesNetherlands
-
GI DynamicsTerminatedObesity | Type 2 Diabetes
-
GI DynamicsCompleted