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

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ClinicalTrials.gov Identifier: NCT00791128
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : December 28, 2016
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
GI Dynamics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 2 Diabetes
Obesity
Intervention Device: GI Liner
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EndoBarrier
Hide Arm/Group Description Subjects implanted with the EndoBarrier for up to 12 months.
Period Title: Overall Study
Started 22
Completed 13
Not Completed 9
Reason Not Completed
Adverse Event             4
Device migration             2
non-compliance by subject             2
abdominal tumor, unrelated to device             1
Arm/Group Title EndoBarrier Liner Device
Hide Arm/Group Description Subjects implanted with the EndoBarrier for up to 12 months.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
46.2  (10.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
19
  86.4%
Male
3
  13.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Brazil Number Analyzed 22 participants
22
 100.0%
Baseline Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 22 participants
119.2  (22.87)
Percent of glycosylated hemoglobin  
Mean (Standard Deviation)
Unit of measure:  Percent of glycosylated hemoglobin
Number Analyzed 22 participants
8.9  (1.66)
1.Primary Outcome
Title % of Excess Weight Loss (EWL)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EndoBarrier
Hide Arm/Group Description:
Subjects implanted with the EndoBarrier for up to 12 months.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: % excess weight loss
37.7  (13.6)
2.Secondary Outcome
Title HbA1c Values at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EndoBarrier
Hide Arm/Group Description:
Subjects implanted with the EndoBarrier for up to 12 months.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: HbA1c (%)
6.6  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EndoBarrier
Hide Arm/Group Description Subjects implanted with the EndoBarrier for up to 12 months.
All-Cause Mortality
EndoBarrier
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
EndoBarrier
Affected / at Risk (%) # Events
Total   2/22 (9.09%)    
Cardiac disorders   
Cardiac Arrhythmia * 1  1/22 (4.55%)  1
Acute myocardial infarction * 1  1/22 (4.55%)  1
Supra-ventricular tachycardia * 1  1/22 (4.55%)  1
Gastrointestinal disorders   
Vomiting * 1  2/22 (9.09%)  2
Abdominal neoplasm * 1  1/22 (4.55%)  1
Nausea * 1  1/22 (4.55%)  1
Gastric hemorrhage * 1  1/22 (4.55%)  1
General disorders   
Asthenia * 1  1/22 (4.55%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  1/22 (4.55%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/22 (4.55%)  1
Vascular disorders   
Varicose vein * 1  1/22 (4.55%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EndoBarrier
Affected / at Risk (%) # Events
Total   22/22 (100.00%)    
Gastrointestinal disorders   
Abdominal distention * 1  3/22 (13.64%)  3
Abdominal pain lower * 1  2/22 (9.09%)  2
Abdominal pain upper * 1  20/22 (90.91%)  64
Constipation * 1  2/22 (9.09%)  2
Diarrhea * 1  3/22 (13.64%)  3
Hemorrhoids * 1  2/22 (9.09%)  2
Nausea * 1  12/22 (54.55%)  23
Vomiting * 1  14/22 (63.64%)  30
General disorders   
Asthenia * 1  11/22 (50.00%)  11
Infections and infestations   
Influenza * 1  3/22 (13.64%)  3
Nasopharyngitis * 1  3/22 (13.64%)  3
Urinary Tract Infection * 1  3/22 (13.64%)  3
Injury, poisoning and procedural complications   
Procedural nausea * 1  10/22 (45.45%)  13
Procedural vomiting * 1  8/22 (36.36%)  8
Investigations   
Blood cholesterol increased * 1  4/22 (18.18%)  4
Blood iron decreased * 1  3/22 (13.64%)  3
High density lipoprotein decreased * 1  5/22 (22.73%)  5
Metabolism and nutrition disorders   
Hypoglycemia * 1  2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders   
Back pain * 1  13/22 (59.09%)  21
Nervous system disorders   
Dizziness * 1  3/22 (13.64%)  3
Headache * 1  4/22 (18.18%)  6
Psychiatric disorders   
Anxiety * 1  2/22 (9.09%)  2
Panic reaction * 1  2/22 (9.09%)  2
Skin and subcutaneous tissue disorders   
Alopecia * 1  6/22 (27.27%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Project Manager, Clinical and Regulatory
Organization: GI Dynamics, Inc.
Phone: 781.357.3263
EMail: kwoessner@gidynamics.com
Layout table for additonal information
Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT00791128    
Other Study ID Numbers: 06-6
First Submitted: November 12, 2008
First Posted: November 14, 2008
Results First Submitted: November 1, 2016
Results First Posted: December 28, 2016
Last Update Posted: June 1, 2017