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Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

NCT ID: NCT01135472

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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NEXIUM HEALTHY VOLUNTEERS BLOOD DRAW to measure gastrin levels in healthy volunteers while taking nexium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nexium

ARM 1: NEXIUM 40MG ONCE DAILY, ARM 2: NEXIUM 40MG TWICE DAILY, ARM 3: NEXIUM 80MG TWICE DAILY

Group Type EXPERIMENTAL

Esomeprazole Magnesium

Intervention Type DRUG

NEXIUM 40MG ONCE DAILY FOR 7 DAYS WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 40MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 80MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD.

Interventions

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Esomeprazole Magnesium

NEXIUM 40MG ONCE DAILY FOR 7 DAYS WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 40MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 80MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fouad Kandeel, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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08197

Identifier Type: -

Identifier Source: org_study_id