Growth Hormone Evaluation in the Elderly People

Aging Clinical Trial

Official title:

Growth Hormone Evaluation in the Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240043
• Other study ID #: 185/09
• Secondary ID: Memo n 019/10
• Status: Completed
• Phase: N/A
• First received: August 31, 2014
• Last updated: September 11, 2014
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with secretion of GH.

Description:

subjects over 65 years old were recruited from the geriatric ambulatory unit of our hospital to voluntarily participate in a research study concerning the GH and ACTH axis in the elderly, which included the realization of the glucagon stimulation test as the first phase of the study.

The GST (Glucagen® Hypokit, Novo Nordisk A/S, Denmark) was the chosen test to assess both ACTH and GH release because of its few known contraindications and mild side effects. It is a provocative test to evaluate GH and ACTH axis, i.e, a diagnostic test, without therapeutic effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• elderly people above 65 years old with comorbidities peculiar to their age (such as hypertension, diabetes, dyslipidemia, parkinson disease) or without comorbidities

Exclusion Criteria:

• pituitary disease, severe acute disease, terminal renal chronic disease, active malignant cancer, the presence of any other disease that could interfere with the somatotrophic axis evaluation, and the contraindications for glucagon administration (pheochromocytoma, insulinoma and malnourishment).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• growth hormone secretion
The glucagon stimulation test (GST) was performed by intramuscular injection of 1 mg of glucagon (Glucagen® Hypokit, Novo Nordisk A/S, Denmark). The blood samples were collected at baseline and after 90 minutes, 120 minutes, 150 minutes and 180 minutes of glucagon injection for GH and cortisol measurements. The subjects were recumbent during the test, and a cannula was maintained in a vein in the arm or forearm with a saline solution slowly infused to avoid multiple punctures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition in the elderly people according with GH secretion	To realize Dual-energy X-ray absorptiometry (DEXA) to evaluate body composition after the realization of the Glucagon stimulation test. It could take some time to be done because of availability of the equipment	up to 3 months	Yes
Primary	Growth Hormone Secretion in the elderly people using glucagon stimulation test (GST)		up to one week	Yes
Secondary	ACTH release in the elderly people using GST	ACTH: adrenocorticotrophic hormone	up to one week	Yes