Trial Outcomes & Findings for Study for Pre-Surgical Weight Loss in Type II Diabetes Patients (NCT NCT00791128)
NCT ID: NCT00791128
Last Updated: 2017-06-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
12 months
Results posted on
2017-06-01
Participant Flow
Participant milestones
| Measure |
EndoBarrier
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
EndoBarrier
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Device migration
|
2
|
|
Overall Study
non-compliance by subject
|
2
|
|
Overall Study
abdominal tumor, unrelated to device
|
1
|
Baseline Characteristics
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Baseline characteristics by cohort
| Measure |
EndoBarrier Liner Device
n=22 Participants
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 10.45 • n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
Brazil
|
22 Participants
n=93 Participants
|
|
Baseline Weight
|
119.2 kg
STANDARD_DEVIATION 22.87 • n=93 Participants
|
|
Percent of glycosylated hemoglobin
|
8.9 Percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.66 • n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPercent 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
Outcome measures
| Measure |
EndoBarrier
n=13 Participants
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
% of Excess Weight Loss (EWL)
|
37.7 % excess weight loss
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
EndoBarrier
n=13 Participants
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
HbA1c Values at 12 Months
|
6.6 HbA1c (%)
Standard Deviation 1.1
|
Adverse Events
EndoBarrier
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EndoBarrier
n=22 participants at risk
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal neoplasm
|
4.5%
1/22 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Asthenia
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Varicose vein
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrhythmia
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Supra-ventricular tachycardia
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
EndoBarrier
n=22 participants at risk
Subjects implanted with the EndoBarrier for up to 12 months.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
13.6%
3/22 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
90.9%
20/22 • Number of events 64
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
54.5%
12/22 • Number of events 23
|
|
Gastrointestinal disorders
Vomiting
|
63.6%
14/22 • Number of events 30
|
|
General disorders
Asthenia
|
50.0%
11/22 • Number of events 11
|
|
Infections and infestations
Influenza
|
13.6%
3/22 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
3/22 • Number of events 3
|
|
Infections and infestations
Urinary Tract Infection
|
13.6%
3/22 • Number of events 3
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
45.5%
10/22 • Number of events 13
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
36.4%
8/22 • Number of events 8
|
|
Investigations
Blood cholesterol increased
|
18.2%
4/22 • Number of events 4
|
|
Investigations
Blood iron decreased
|
13.6%
3/22 • Number of events 3
|
|
Investigations
High density lipoprotein decreased
|
22.7%
5/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.1%
2/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
59.1%
13/22 • Number of events 21
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Number of events 3
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • Number of events 6
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • Number of events 2
|
|
Psychiatric disorders
Panic reaction
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.3%
6/22 • Number of events 7
|
Additional Information
Project Manager, Clinical and Regulatory
GI Dynamics, Inc.
Phone: 781.357.3263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place