Skip to main content
OpenTrials
Completed

NCT Number: NCT02240043

Growth Hormone Evaluation in the Elderly People

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

growth hormone secretion

Other

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.

Primary outcomes

  1. Growth Hormone Secretion in the elderly people using glucagon stimulation test (GST)

    Time frame: up to one week

Secondary outcomes

  1. ACTH release in the elderly people using GST

    Time frame: up to one week

    ACTH: adrenocorticotrophic hormone

Other outcomes

  1. Body composition in the elderly people according with GH secretion

    Time frame: up to 3 months

    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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2014
Registry last updated
Sep 15, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.