HealthyPhase 1NCT01135472
Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers
A Phase 1 study testing Esomeprazole Magnesium in people with Healthy, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Esomeprazole Magnesium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2010to 1 Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65
- healthy
- free of clinical signs of diabetes, peptic ulcer, liver or kidney disease,autoimmune disease, or any acute chronic infection.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Esomeprazole Magnesium
- Keywords
- NEXIUM, HEALTHY VOLUNTEERS, BLOOD DRAW, to measure gastrin levels in healthy volunteers while taking nexium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole MagnesiumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nexium | Experimental | ARM 1: NEXIUM 40MG ONCE DAILY, ARM 2: NEXIUM 40MG TWICE DAILY, ARM 3: NEXIUM 80MG TWICE DAILY Receives: Drug: Esomeprazole Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the extent to which Nexium increases endogenous gastrin concentrations with 3 different treatment doses and least amount of side effects.
Measured: 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.
Measured: Every 7 days during non-treatment period.
Secondary outcomes (2)
To monitor the effect of Nexium on the plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin during 3 different treatment doses.
Measured: 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.
Measured: Every 7 days during non-treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study start13 Jul 2010
- Primary completion1 Apr 2012
- Study completion1 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fouad Kandeel, MD, Ph.D., Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135472
- Sponsor's protocol ID
- 08197
- Status last verified
- Oct 2026
- First submitted
- 28 May 2010
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01135472
- Acronym / sponsor ID
- 08197
- Conditions
- Healthy
- Keywords
- NEXIUM, HEALTHY VOLUNTEERS, BLOOD DRAW, to measure gastrin levels in healthy volunteers while taking nexium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2010 (actual)
- Primary completion
- 1 Apr 2012 (actual)
- Study completion
- 1 Apr 2012 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nexium | Experimental | Drug: Esomeprazole MagnesiumARM 1: NEXIUM 40MG ONCE DAILY, ARM 2: NEXIUM 40MG TWICE DAILY, ARM 3: NEXIUM 80MG TWICE DAILY |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-65
- healthy
- free of clinical signs of diabetes, peptic ulcer, liver or kidney disease,autoimmune disease, or any acute chronic infection.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole MagnesiumNEXIUM 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. | Drug | Nexium |
Primary outcome
To measure the extent to which Nexium increases endogenous gastrin concentrations with 3 different treatment doses and least amount of side effects.
Time frame: 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.
Time frame: Every 7 days during non-treatment period.
2 secondary outcomes
To monitor the effect of Nexium on the plasma concentrations of glucose, insulin, c-peptide, glucagon, and somatostatin during 3 different treatment doses.
Time frame: 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.
Time frame: Every 7 days during non-treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fouad Kandeel, MD, Ph.D. principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esomeprazole Magnesium in people with Healthy, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the extent to which Nexium increases endogenous gastrin concentrations with 3 different treatment doses and least amount of side effects. (time frame: Every 3 days during treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.