The effect of bile acid binding with colesevelam on blood sugar levels in patients after gastric bypass surgery and galbladder surgery : meal test study

The effect of bile acid binding with colesevelam on postprandial glucose concentrations in patients after RYGB and cholecystectomy : a meal test study - Colesevelam hypOglycemia Bile acid binding in Rygb : a meAl test study : COBRA

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000667-74-NL

Enrollment

Registered

2021-10-22

Start date

2021-11-30

Completion date

Unknown

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Bariatric Hypoglycemia MedDRA version: 21.0 Level: LLT Classification code 10059038 Term: Postprandial hypoglycemia System Organ Class: 100000004861

Interventions

Trade Name: Cholestagel Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): During the MMT : Number of patients with a hypoglycemic episode (glucose < 3.0 mmol/L) Glucose Area under the curve between 0-60, 60-120 and 60 to 180 minutes (glucose AUC0-60, AUC60-120, AUC60-180min), Bile acids and derivatives, GLP-1, PPY, FGF-19, and insulin, both as peaks and as AUC0-60 min . Glucose kinetics (absorption rate, endogenous glucose production) using stable isotope dilution of glucose ;Timepoint(s) of evaluation of this end point: time points have been addressed in the above section	—

Measure

Time frame

Secondary end point(s): During the MMT : Number of patients with a hypoglycemic episode (glucose < 3.0 mmol/L) Glucose Area under the curve between 0-60, 60-120 and 60 to 180 minutes (glucose AUC0-60, AUC60-120, AUC60-180min), Bile acids and derivatives, GLP-1, PPY, FGF-19, and insulin, both as peaks and as AUC0-60 min . Glucose kinetics (absorption rate, endogenous glucose production) using stable isotope dilution of glucose ;Timepoint(s) of evaluation of this end point: time points have been addressed in the above section

—

Countries

Netherlands

Contacts

Public ContactMedical Center Leeuwarden

Medical Center Leeuwarden

CON-Wetenschappelijkonderzoek@mcl.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026