post gastric bypass hyperinsulinemic hypoglycemia
Conditions
Interventions
colesevelam 625mg tablets, 6 tablets dissolved in water ingested together
Sponsors
Medical Center Leeuwarden
Eligibility
Inclusion criteria
Inclusion criteria: RYGB patients, 2 years or more after surgery with a history of cholecystectomy, 20 to 60 years of age, with a stable weight (+/- 5 Kg in last 3 months) and without complaints of PBH
Exclusion criteria
Exclusion criteria: - (history of ) diabetes - hypertriglyceridemia - Known gastro-intestinal disease or history of gastro-intestinal disease, e.g. celiac disease, inflammatory bowel disease - Known addiction behaviour - Suspected compliance problems - Intolerance to colesevelam - Renal or hepatic insufficiency - Medication influencing glucose metabolism - Medication influencing bile-acid metabolism, e.g. ursodeoxycholic acid - Critical medication of which absorption can be compromised by colesevelam and can not be ingested at least 4 hours before or later than colesevelam(e.g. levothyroxine, verapamil, fenytoïne, glibenclamide, glimepiride, ciclosporin, olmesartan, ethinylestradiol (oral contraceptives) - Pregnancy or pregnancy planning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose nadir during the MMT in mmol/L | — |
Secondary
| Measure | Time frame |
|---|---|
| During the MMT : Number of patients with a hypoglycemic episode (glucose < 3.0 mmol/L) Glucose Area under the curve between 60 and 180 minutes (glucose 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 Satiety and hunger score, using a Visual Analogue Scale (VAS), 0-10 cm Dumping complaints using a modified Dumping Severity Score (DSS) | — |
Contacts
Public ContactLoek de Heide
Medisch Centrum Leeuwarden
Outcome results
None listed