Growth Hormone Evaluation in the Elderly People
2 other identifiers
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
Typical duration for not_applicable
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
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 31, 2014
CompletedFirst Posted
Study publicly available on registry
September 15, 2014
CompletedSeptember 15, 2014
September 1, 2014
1.9 years
August 31, 2014
September 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Growth Hormone Secretion in the elderly people using glucagon stimulation test (GST)
up to one week
Secondary Outcomes (1)
ACTH release in the elderly people using GST
up to one week
Other Outcomes (1)
Body composition in the elderly people according with GH secretion
up to 3 months
Study Arms (1)
growth hormone secretion
OTHERThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- elderly people above 65 years old with comorbidities peculiar to their age (such as hypertension, diabetes, dyslipidemia, parkinson disease) or without comorbidities
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25481820DERIVED
Study Officials
- STUDY DIRECTOR
Flávia L Conceição, PhD
Hospital Universitário Clementino Fraga Filho - UFRJ
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 31, 2014
First Posted
September 15, 2014
Study Start
September 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
September 15, 2014
Record last verified: 2014-09