The effect of bile acid binding with colesevelam on blood sugar levels in patients after gastric bypass surgery and galbladder surgery : meal test study
Phase 1
- Conditions
- Post Bariatric HypoglycemiaMedDRA version: 21.0Level: LLTClassification code 10059038Term: Postprandial hypoglycemiaSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2021-000667-74-NL
- Lead Sponsor
- Medisch Centrum Leeuwarden BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
patients 20-60 years, 2 years or more after RYGB and with a history of a cholecystectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
known with post bariatric hypoglycemia
(former) diabetic
hypertriglyceridemia
renal or liver disease
addiction behaviour
medication use that will be interfered ith by colesevelam
pregnancy (planning)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of the bile acid sequestrant colesevelam on glucose concentrations during a liquid meal test (MMT) in patients after RYGB with a previous cholecystectomy (CCx);Secondary Objective: measurement of (GI)-hormones (insulin, GLP-1, PYY, FGF19) and bile acids and glucose flux during the MMT with and without bile acid binding with colesevelam;Primary end point(s): Glucose nadir during the MMT in mmol/L;Timepoint(s) of evaluation of this end point: between time zero and 180 minutes after the start of the MMT
- Secondary Outcome Measures
Name Time Method Secondary end point(s): During the MMT : <br>Number of patients with a hypoglycemic episode (glucose < 3.0 mmol/L)<br>Glucose Area under the curve between 0-60, 60-120 and 60 to 180 minutes (glucose AUC0-60, AUC60-120, AUC60-180min), <br>Bile acids and derivatives, GLP-1, PPY, FGF-19, and insulin, both as peaks and as AUC0-60 min .<br>Glucose kinetics (absorption rate, endogenous glucose production) using stable isotope dilution of glucose<br><br>;Timepoint(s) of evaluation of this end point: time points have been addressed in the above section