Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Esomeprazole Magnesium

• Registration Number: NCT01135472
• Lead Sponsor: City of Hope Medical Center

Brief Summary

This dose response study is proposed to explore the extent to which Nexium increases endogenous gastrin concentrations and to assess whether Nexium treatment may be useful in the setting of islet cell transplantation for type 1 diabetes to expand islet cells in vivo after transplant.

Detailed Description

Islet transplantation has been shown to effectively treat type 1 diabetes by stabilizing blood glucose control while reducing/eliminating the need for exogenous insulin injections. However, for reasons still not fully understood, islet graft function tends to decline with time after transplant. Gastrin has been identified as a growth factor capable of stimulating islet cell expansion. Proton pump inhibitors are known to increase endogenous gastrin concentrations. This dose response study is proposed to explore the extent to which Nexium increases endogenous gastrin concentrations in healthy volunteers and to assess whether Nexium treatment may be useful in expanding islet cells in patients with type 1 diabetes. Three Nexium dose levels will be tested to determine the optimal dose for increasing plasma gastrin levels. The effect of Nexium on plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin will also be monitored.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• age 18-65
• healthy
• free of clinical signs of diabetes, peptic ulcer, liver or kidney disease,autoimmune disease, or any acute chronic infection.

Exclusion Criteria

• history or clinical signs of diabetes
• history of liver or kidney disease
• positive H-pylori status
• currently using a proton pump inhibitor
• prior hypersensitivity to Nexium
• pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nexium	Esomeprazole Magnesium	ARM 1: NEXIUM 40MG ONCE DAILY, ARM 2: NEXIUM 40MG TWICE DAILY, ARM 3: NEXIUM 80MG TWICE DAILY

Primary Outcome Measures

Name	Time	Method
To measure the extent to which Nexium increases endogenous gastrin concentrations with 3 different treatment doses and least amount of side effects.	Every 3 days during treatment.
To measure the extent to which Nexium increases endogenous gastrin concentrations and returns to baseline levels during the two week non-treatment period.	Every 7 days during non-treatment period.

Secondary Outcome Measures

Name	Time	Method
To monitor the effect of Nexium on the plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin during 3 different treatment doses.	Every 3 days during treatment.
To monitor the effect of Nexium on the plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin during the two week non-treatment period.	Every 7 days during non-treatment period.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States