CompletedPhase 4

Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Lead sponsor

Hvidovre University Hospital

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•GLP-1 secretion (evaluated by iAUC)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02952963

Org study IDIJ-GALDE3-16

Timeline

Milestones

Study first posted2016-11-02estimated

Last update posted2020-11-30actual

Study start2016-10 (month precision)

Primary completion2017-12actual (month precision)

Study completion2020-11actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweight

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Uncomplicated RYGB performed minimum 3 months prior to the study.

•Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB

Exclusion criteria

•Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB

•Dysregulated thyroid diseases, use of antithyroid treatment.

•Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.

•Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)

•Cholecystectomy.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Glucose levels

Time frame:-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes

descriptive

Secondary/protocol endpoint

Insulin secretion

Time frame:-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes

descriptive

Secondary/protocol endpoint

C-peptide secretion

Time frame:-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes

descriptive

Other (unclassified)

9 endpoints

Primary/protocol endpoint/low confidence

GLP-1 secretion (evaluated by iAUC)

Time frame:-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.

descriptive