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

NCT02413944 | Completed Phase 4

• 1 other identifier: BnaiZionMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

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.

  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.

  1 year

Study Arms (1)

healthy volunteers

EXPERIMENTAL

ACTH stimulation test

Procedure: ACTH stimulation test

Interventions

ACTH stimulation test PROCEDURE

ACTH stimulation test

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion MC

Haifa, Israel

Location

Study Officials

• Leonard Saiegh

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)