Trial Outcomes & Findings for EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus (NCT NCT02769728)

NCT ID: NCT02769728

Last Updated: 2024-04-08

Results Overview

insulin sensitivity: measured by mean glucose infusion rate (in a hyperinsulinaemic-euglycaemic clamp) (value at 9 months minus value at baseline)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 9 months

Results posted on

2024-04-08

Participant Flow

Participants were recruited at the University Hospital Graz (LKH-Univ. Klinikum Graz) between January 2016 and September 2016. The first participant was enrolled in February 2016 and the last participant was enrolled in October 2016.

11 participants were screened. Due to 1 withdrawal of informed consent 10 participants were enrolled in the trial and got the endobarrier device implanted.

Participant milestones

Participant milestones
Measure	EndoBarrier EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Overall Study STARTED	10
Overall Study Implantation of the Endobarrier Device	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EndoBarrier n=10 Participants EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Age, Continuous	48 years STANDARD_DEVIATION 9 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Austria	10 participants n=93 Participants
Body weight	121.2 kilogram STANDARD_DEVIATION 18.5 • n=93 Participants
Height	1.68 meter STANDARD_DEVIATION 0.1 • n=93 Participants
BMI	43.3 kilograms divided by height in meters sq STANDARD_DEVIATION 5.0 • n=93 Participants
Waist circumference	128 centimeter STANDARD_DEVIATION 12 • n=93 Participants
Hip circumference	128 centimeter STANDARD_DEVIATION 9 • n=93 Participants
Waist to hip ratio	1 Ratio STANDARD_DEVIATION 0.1 • n=93 Participants
systolic blood pressure	133 millimeters of mercury STANDARD_DEVIATION 19 • n=93 Participants
diastolic blood pressure	88 millimeters of mercury STANDARD_DEVIATION 12 • n=93 Participants
Diabetes duration in years	7 years STANDARD_DEVIATION 6 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 9 months

insulin sensitivity: measured by mean glucose infusion rate (in a hyperinsulinaemic-euglycaemic clamp) (value at 9 months minus value at baseline)

Outcome measures

Outcome measures
Measure	EndoBarrier n=10 Participants EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Changes in Insulin Sensitivity	0.97 milligram per kilogram per minute Standard Deviation 1.36

SECONDARY outcome

Timeframe: Baseline and 9 months

Glucagon like peptide -1 levels measured before the Meal Tolerance Test (value at 9 months minus value at baseline)

Outcome measures

Outcome measures
Measure	EndoBarrier n=10 Participants EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Changes in Glucagon Like Peptide -1 Levels	18.2 picomole per Liter Standard Deviation 11.4

SECONDARY outcome

Timeframe: Baseline and 9 months

Gut permeability measured by the Lactulose/Mannitol Test (value at 9 months minus value at baseline)

Outcome measures

Outcome measures
Measure	EndoBarrier n=10 Participants EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Changes in Gut Permeability	0.0039 lactulose to mannitol ratio Standard Deviation 0.072

SECONDARY outcome

Timeframe: Baseline and 9 months

Dual-energy X-ray absorptiometry fat mass (value at 9 months minus value at baseline)

Outcome measures

Outcome measures
Measure	EndoBarrier n=10 Participants EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Changes in Weight	53.6 kilogram Standard Deviation 15.2

SECONDARY outcome

Timeframe: Baseline and 9 months

The UKPDS Risk Engine provides risk estimates and 95% confidence intervals, in individuals with type 2 diabetes not known to have heart disease, for non-fatal coronary heart disease These can be calculated for any given duration of type 2 diabetes based on current age, sex, ethnicity, smoking status, presence or absence of atrial fibrillation and levels of HbA1c, systolic blood pressure, total cholesterol and HDL cholesterol. Units on a scale: 10 year risk to suffer non-fatal coronary heart disease (in %) lower scores mean a better outcome (value at 9 months minus value at baseline)

Outcome measures

Outcome measures
Measure	EndoBarrier n=10 Participants EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Changes in UKPDS Risk Score for Coronary Heart Disease	16.3 units on a scale Standard Deviation 20.4

Adverse Events

EndoBarrier

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EndoBarrier n=10 participants at risk EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
General disorders Dehydration	10.0% 1/10 • Number of events 1 • 36 weeks
Gastrointestinal disorders duodenal ulcer	10.0% 1/10 • Number of events 1 • 36 weeks
Gastrointestinal disorders nausea and vomiting	10.0% 1/10 • Number of events 1 • 36 weeks
General disorders haemorrhoid bleeding	10.0% 1/10 • Number of events 1 • 36 weeks

Other adverse events

Other adverse events
Measure	EndoBarrier n=10 participants at risk EndoBarrier will be implemented for 9 months. EndoBarrier: implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Gastrointestinal disorders Feeling bloated after gastroscopy	90.0% 9/10 • Number of events 9 • 36 weeks

Additional Information

Prof. Harald Sourij

Medical University of Graz

Phone: 0316 385 81310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place