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Completed

NCT Number: NCT02413944

Standardized 1µg Adrenocorticotropic Hormone Stimulation Test, and Salivary Cortisol Concentration During the Test

Study objectives: First, to determine whether intravenous injection of 1 mcg adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides reliable results of cortisol response, and whether this method would replace the conventional technique of injecting ACTH by a needle directly into a peripheral vein. Secondly, to determine salivary free cortisol concentration during the test in healthy controls.

Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous short cannula appears to be feasible and simple method. On the other hand, injection of ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by technical problems in subjects with challenging veins. The investigators suppose that, both methods would have the same yield in predicting cortisol response.

Salivary free cortisol test has an evolving importance in assessing the adrenal function. This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The investigators will examine the concentration of salivary free cortisol during ACTH stimulation test, in order to determine level range in normal controls.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bnai Zion MC

Haifa, Israel

About this study

The study will include 20 healthy participants of both sexes, aged 18-70 years, that have no clinical suspicion of hypoadrenalism, or any active medical condition or treatment that might alter blood cortisol levels. Pregnant women and patients whose medical or mental condition precludes obtaining informed consent will be excluded.

In the morning of the first visit, 1 mcg of ACTH1-24 will be injected directly into a peripheral vein. Blood and salivary samples will be drawn before injection, and 30 minutes after. Salivary cortisol will be drawn also 60 minutes after injection. At least two days later, in the morning of the second visit, 1 mcg of ACTH1-24 will be injected through short cannula in a peripheral vein, followed by injection of 5 ml of normal saline. Blood and salivary samples will be drawn before injection, and 30 minutes after. Salivary cortisol will be drawn also 60 minutes after injection. Blood cortisol results and salivary free cortisol results will be compared between tests.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy participants of both sexes
  • aged 18-70 year

Exclusion criteria

  • any clinical suspicion of hypoadrenalism, or any active medical condition or treatment that might alter blood cortisol levels
  • pregnant women and patients whose medical or mental condition precludes obtaining informed consent

Treatment and study plan

ACTH stimulation test

Procedure

ACTH stimulation test

Primary outcomes

  1. Serum cortisol concentrations during intravenous injection of 1 mcg adrenocorticotropic hormone through short cannula and during direct intravenous injection, in healthy participants.

    Time frame: 1 year

Secondary outcomes

  1. Salivary free cortisol concentrations during intravenous injection of 1 mcg adrenocorticotropic hormone through short cannula and during direct intravenous injection, in healthy participants.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

Standardized Protocol for 1µg Adrenocorticotropic Hormone (ACTH) Stimulation Test, Minimizing Technical Issues That Could Influence Test Accuracy; and Determining Salivary Free Cortisol Concentration in Healthy Controls During the Test

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2015
Registry last updated
Oct 27, 2016

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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