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Completed

NCT Number: NCT01135472

Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole Magnesium

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2010
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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