Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with frequent sampling (FSIGT) followed by minimal model analysis. In a randomized single-blind cross-over design, the subjects will receive either hydrocortisone or placebo 4 minutes before an intravenous glucose load.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJune 1, 2011
January 1, 2009
4 months
July 1, 2008
May 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma insulin, glucose and C-peptide
Minutes: -10, -5, 0, 3, 4, 5, 6, 8, 10, 15, 20, 30, 40, 60, 80, 100, 120, 150, 180
Secondary Outcomes (1)
Plasma levels of appetite-regulatory hormones: ghrelin, PYY and nesfatin-1.
Minutes: -10, 0, 30, 60, 120, 180
Interventions
0.6 mg/kg body weight, intravenous bolus given at time-point minus 4'
1ml/kg body weight, intravenous bolus given at time-point 0'
Eligibility Criteria
You may qualify if:
- Healthy subjects
- No concomitant medication
- BMI \< 25 kg/m2
- Age: 18-60 years old
You may not qualify if:
- Impaired glucose tolerance or diabetes mellitus
- Hyperthyroidism, hypothyroidism
- Hepatic, renal or cardiovascular diseases
- Malignancies
- History of medical therapy within 3 weeks prior to enrolment into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna
Vienna, A-1090, Austria
Related Publications (1)
Vila G, Krebs M, Riedl M, Baumgartner-Parzer SM, Clodi M, Maier C, Pacini G, Luger A. Acute effects of hydrocortisone on the metabolic response to a glucose load: increase in the first-phase insulin secretion. Eur J Endocrinol. 2010 Aug;163(2):225-31. doi: 10.1530/EJE-10-0282. Epub 2010 May 18.
PMID: 20484150RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Luger, MD
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
June 1, 2011
Record last verified: 2009-01