Pasireotide in the treatment of low blood sugar following gastric bypass surgery

Phase 1

• Conditions: Postprandial reactive hypoglycemia in patients with prior Roux-en-Ygastric bypass surgery.; MedDRA version: 20.1Level: LLTClassification code 10059038Term: Postprandial hypoglycemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-001067-23-DK
• Lead Sponsor: Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-05
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

Prior participation in our study 'Treatment of hypoglycemia following gastric bypass surgery (EudraCT 2015-001086-50).
hemoglobin > 7,3 mmol/L,
Age 20-60 years
Normal ECG
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 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy, breastfeeding, allergic reactions to the study medicine, treatment for cardiovascular disease, treatment for thyroid disease, treatment with antipsychotica or trycyclic antidepressants, impaired liver function (Child Pugh C)

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 effects of both 75 ug pasireotide (P75) and 150 ug pasireotide (P150) on the postprandial blood glucose response in RYGB operated patients with hypoglycemia.;Secondary Objective: - To compare the effects of P75 and P150 on the postprandial blood glucose response with the effects of 300 ug pasireotide (P300) and a baseline recording with no treatment (NT) (results from a prior study with the same study participants).<br>- to investigate the effects of P75 and P150 on the postprandial secretion of insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine and epinephrine, and to compare these effects with the effects of P300 and NT on the same parameters (results from a prior study with the same study participants). ;Primary end point(s): The postprandial blood glucose response for P75 and P150, defined as the incremental area under the curve for glucose (iAUCglucose);Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - nadir glucose, peak glucose, time in hyperglycemia (time with glucose values =7,8 mmol/l) and time in hypoglycemia (time with glucose values =3,9 mmol/l) for both P75 and P150.<br>- Area under the curve for insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine, epinephrine (AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine) for both P75 og P150.<br>- Changes in heart rate (HR) and blood pressure (BP) for both P75 and P150.<br>- Comparison of iAUCglucose, nadir glucose, peak glucose, time in hyperglycemia, time in hypoglycemia, AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine, HR and BP for P75 and P150 with the same parameters for P300 and NT (results from a prior study with the same study participants).;Timepoint(s) of evaluation of this end point: End of study