Clinical trial NCT01135472: Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers
Official title: Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: NEXIUM
HEALTHY VOLUNTEERS
BLOOD DRAW
to measure gastrin levels in healthy volunteers while taking nexium
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: To measure the extent to which Nexium increases endogenous gastrin concentrations with 3 different treatment doses and least amount of side effects.
timeFrame: Every 3 days during treatment.
measure: To measure the extent to which Nexium increases endogenous gastrin concentrations and returns to baseline levels during the two week non-treatment period.
timeFrame: Every 7 days during non-treatment period.
Secondary outcomes:
measure: To monitor the effect of Nexium on the plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin during 3 different treatment doses.
timeFrame: Every 3 days during treatment.
measure: 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.
timeFrame: Every 7 days during non-treatment period.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Fouad Kandeel, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: