Growth Hormone Evaluation in the Elderly People

NCT ID: NCT02240043

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-08-31

Brief 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.

Detailed 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.

Conditions

Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

growth hormone secretion

The elderly had common morbidities peculiar to their age, such as systemic arterial hypertension, diabetes mellitus, Parkinson's disease, initial stages of senile dementia, and osteoporosis.

Group Type: OTHER

growth hormone secretion

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Ana Beatriz Winter Tavares

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flávia L Conceição, PhD

Role: STUDY_DIRECTOR

Hospital Universitário Clementino Fraga Filho - UFRJ

References

Tavares AB, Seixas-da-Silva IA, Silvestre DH, Paixao CM Jr, Vaisman M, Conceicao FL. Potential risks of glucagon stimulation test in elderly people. Growth Horm IGF Res. 2015 Feb;25(1):53-6. doi: 10.1016/j.ghir.2014.11.002. Epub 2014 Nov 29.

Reference Type: DERIVED

PMID: 25481820 (View on PubMed)

Other Identifiers

Memo n 019/10

Identifier Type: REGISTRY

Identifier Source: secondary_id

185/09

Identifier Type: -

Identifier Source: org_study_id