The effect of bile acid binding with colesevelam on postprandial glucose concentrations in patients after RYGB and cholecystectomy : a meal test study

Phase 3

Completed

• Conditions: 10018424; post bariatric hypoglycemia hypoglycemia after gastric bypass surgery

• Registration Number: NL-OMON50934
• Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-25
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

patients 20-60 years, 2 years or more after RYGB and with a history of a
cholecystectomy

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)
bowel or choledochusobstruction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Glucose nadir during the MMT in mmol/L</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>During the MMT :<br /><br>Number of patients with a hypoglycemic episode (glucose < 3.0 mmol/L)<br /><br>Glucose Area under the curve between 60 and 180 minutes (glucose AUC60-180min),<br /><br>Bile acids and derivatives, GLP-1, PPY, FGF-19, and insulin, both as peaks and<br /><br>as AUC0-60 min .<br /><br>Glucose kinetics (absorption rate, endogenous glucose production) using stable<br /><br>isotope dilution of glucose</p><br>