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NCT00139945 Clinical Trial

Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients

Hypopituitarism Clinical Trial

Official title:
Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139945
Other study ID # 2004/102
Secondary ID
Status Completed
Phase N/A
First received August 30, 2005
Last updated January 19, 2010
Start date October 2005
Est. completion date March 2007

Study information
Verified date January 2010
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Age between 18 and 60 yrs.

- Verified hypopituitarism

- Unchanged substitution treatment through 3+ months

- Unchanged additional medical treatment

- Oral and written informed consent

Exclusion Criteria:

- Age below 18 or above 60 yrs.

- Diabetes mellitus

- body mass index > 30

- Fasting hypoglycemia

- Convulsions

- Allergy to trial products

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Human acylated ghrelin
5 pmol/kg body weight per min

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endogenous serum ghrelin levels Same day as intervention No
Secondary Insulin sensitivity, appetite, metabolism, intracellular signal transduction Same day as intervention No
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