N/A N=10 Treatment

EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02769728 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Apr 2024

Primary outcome: Primary: Changes in Insulin Sensitivity — 0.97 milligram per kilogram per minute — p=0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EndoBarrier (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of Graz
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Insulin Sensitivity	0.97	0.001 sig
SECONDARY Changes in Glucagon Like Peptide -1 Levels	18.2	0.081
SECONDARY Changes in Gut Permeability	0.0039	0.114
SECONDARY Changes in Weight	53.6	0.021 sig
SECONDARY Changes in UKPDS Risk Score for Coronary Heart Disease	16.3	1.00

Summary

The aim of the study is to explore short and longer-term effects of the Endobarrier™ implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps. In addition changes in gut peptides and gut permeability after implantation of a removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body weight and body composition, the change in global cardiovascular risk from baseline to 12 months, estimated using the UKPDS risk engine will be recorded.

Eligibility Criteria

Inclusion Criteria

Participant is willing and able to give informed consent for participation in the study.
Type 2 diabetes
BMI 30-49 kg/m²
HbA1c ≥ 6.5% (48 mmol/mol)
Appropriate life style intervention measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months
Person is generally fit for intervention
Person commits to the need for long-term follow-up

Exclusion Criteria

Type 1 diabetes mellitus
Maturity Onset Diabetes of the Young (MODY)
Secondary diabetes due to a specific disease or glucocorticoid therapy
Pregnancy or women of childbearing age without adequate contraception
Women who are breast-feeding
Hypothalamic cause of obesity, Cushing syndrome
Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
History of bariatric surgery or complex abdominal surgery
Inflammatory bowel disease
Pancreatitis
Cholelithiasis
Uncontrolled gastroesophageal reflux
Known upper GI bleeding conditions, e.g. gastric or esophageal varices
Congenital or acquired abnormalities of the upper GI tract, e.g. stenosis
Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Chronic non-steroidal anti-inflammatory drug (NSAID) or aspirin treatment (Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period)
Previous GI surgery that could affect the ability to place the device or the function of the implant
GLP-1 receptor agonist therapy
Known ischaemic heart disease or heart failure
History of stroke
Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of Helicobacter Pylori and were successfully treated)
Iron deficiency and/or iron deficiency anemia
Subjects or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Known malignancy or any other multimorbid patient condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol or would put the participant at an unjustified risk

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02769728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.