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Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

Information source: City of Hope Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Esomeprazole Magnesium (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: City of Hope Medical Center

Official(s) and/or principal investigator(s):
Fouad Kandeel, MD, Ph.D., Principal Investigator, Affiliation: City of Hope Medical Center

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.

Clinical Details

Official title: Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

To measure the extent to which Nexium increases endogenous gastrin concentrations with 3 different treatment doses and least amount of side effects.

To measure the extent to which Nexium increases endogenous gastrin concentrations and returns to baseline levels during the two week non-treatment period.

Secondary outcome:

To monitor the effect of Nexium on the plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin during 3 different treatment doses.

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

City of Hope Medical Center, Duarte, California 91010, United States
Additional Information

Starting date: March 2010
Last updated: December 14, 2012

Page last updated: August 23, 2015

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