Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

Study Overview
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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.

Official Title
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Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Esomeprazole Magnesium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nexium<br>ARM 1: NEXIUM 40MG ONCE DAILY, ARM 2: NEXIUM 40MG TWICE DAILY, ARM 3: NEXIUM 80MG TWICE DAILY | Drug: Esomeprazole Magnesium<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NEXIUM, HEALTHY VOLUNTEERS, BLOOD DRAW, to measure gastrin levels in healthy volunteers while taking nexium