Trial Outcomes & Findings for A Multicenter Study for Pre-Surgical Weight Loss (NCT NCT00830440)

NCT ID: NCT00830440

Last Updated: 2017-05-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-05-17

Participant Flow

Participant milestones

Measure	Control (Diet & Lifestyle Counseling) Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits	EndoBarrier Device EndoBarrier + Diet + Lifestyle counseling 12 Week implant duration EndoBarrier: Monthly visits
Overall Study STARTED	11	32
Overall Study Received Device	0	26
Overall Study Completed 12 Week Follow up	11	24
Overall Study Completed 16 Week Follow up	0	4
Overall Study Completed 24 Week Follow up	0	3
Overall Study COMPLETED	11	24
Overall Study NOT COMPLETED	0	8

Reasons for withdrawal

Measure	Control (Diet & Lifestyle Counseling) Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits	EndoBarrier Device EndoBarrier + Diet + Lifestyle counseling 12 Week implant duration EndoBarrier: Monthly visits
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study unsuccessful procedure	0	4
Overall Study Adverse Event	0	2

Baseline Characteristics

A Multicenter Study for Pre-Surgical Weight Loss

Baseline characteristics by cohort

Measure	EndoBarrier and Diet/Lifestyle Counseling n=26 Participants EndoBarrier + Diet + Lifestyle counseling EndoBarrier: Monthly visits	Control: (Diet and Lifestyle Counseling) n=11 Participants Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits	Total n=37 Participants Total of all reporting groups
Age, Continuous	40.9 years STANDARD_DEVIATION 9.33 • n=5 Participants	41.2 years STANDARD_DEVIATION 10.46 • n=7 Participants	41.0 years STANDARD_DEVIATION 9.53 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Netherlands	26 participants n=5 Participants	11 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 26 subjects received the device. 2 subjects had the device removed before 12 weeks.

Outcome measures

Measure	EndoBarrier/Diet and Lifestyle Counseling/12 Weeks n=24 Participants 12 week implantation period	Control (Diet & Lifestyle Counseling) n=11 Participants Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits
Total Weight Change From Baseline at 12 Weeks in kg	-13.3 kg Standard Deviation 5.83	-5.5 kg Standard Deviation 5.41

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EndoBarrier/Diet and Lifestyle Counseling/12 Weeks n=24 Participants 12 week implantation period	Control (Diet & Lifestyle Counseling) n=11 Participants Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits
% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks	80.8 % participants	27.3 % participants

SECONDARY outcome

Timeframe: Baseline to Week 12 of treatment

Population: Type 2 Diabetes Subjects

Outcome measures

Measure	EndoBarrier/Diet and Lifestyle Counseling/12 Weeks n=8 Participants 12 week implantation period	Control (Diet & Lifestyle Counseling) n=2 Participants Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits
Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12	8 Participants	1 Participants

Adverse Events

EndoBarrier and Diet and Lifestyle Counseling

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Control (Diet & Lifestyle Counseling)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	EndoBarrier and Diet and Lifestyle Counseling n=26 participants at risk EndoBarrier + Diet + Lifestyle counseling EndoBarrier: Monthly visits	Control (Diet & Lifestyle Counseling) n=11 participants at risk Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits
Gastrointestinal disorders Obstruction	3.8% 1/26 • Number of events 1	0.00% 0/11

Other adverse events

Measure	EndoBarrier and Diet and Lifestyle Counseling n=26 participants at risk EndoBarrier + Diet + Lifestyle counseling EndoBarrier: Monthly visits	Control (Diet & Lifestyle Counseling) n=11 participants at risk Diet + Lifestyle counseling Diet + Lifestyle Counseling: Monthly Visits
Gastrointestinal disorders Abdominal pain upper	50.0% 13/26 • Number of events 20	0.00% 0/11
Injury, poisoning and procedural complications Adverse drug reaction	7.7% 2/26 • Number of events 2	0.00% 0/11
Gastrointestinal disorders Duodenal ulcer	30.8% 8/26 • Number of events 8	0.00% 0/11
Gastrointestinal disorders Duodenitis	26.9% 7/26 • Number of events 7	0.00% 0/11
Injury, poisoning and procedural complications Implant site inflammation	19.2% 5/26 • Number of events 5	0.00% 0/11
Gastrointestinal disorders Nausea	42.3% 11/26 • Number of events 12	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Polyp	7.7% 2/26 • Number of events 2	0.00% 0/11
Injury, poisoning and procedural complications Procedural nausea	34.6% 9/26 • Number of events 9	0.00% 0/11
Gastrointestinal disorders Procedural vomiting	15.4% 4/26 • Number of events 4	0.00% 0/11
Skin and subcutaneous tissue disorders Skin ulcer	7.7% 2/26 • Number of events 2	0.00% 0/11
Gastrointestinal disorders Vomiting	7.7% 2/26 • Number of events 3	0.00% 0/11

Additional Information

Manager of Clinical Affairs

GI Dynamics, Inc.

Phone: 781.357.3263

Email: kwoessner@gidynamics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place