IGF-1, Sarcopenia and Mortality: a Cohort Study in Patient With Cognitive Impairment

Cognitive Impairment Clinical Trial

— ISAAC  

Official title:

Insulin Like Growth Factor 1 and Risks of Sarcopenia and Mortality in Patients With Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139410
• Other study ID #: IGF-001
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: May 13, 2014
• Start date: June 2008
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Istituto Superiore di Sanità
• Study type: Observational

Clinical Trial Summary

Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation of this hormone has been reported to influence the genesis of cognitive impairment and dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosis of cognitive impairment (MMSE < 24)

• Age > 65 ys

Exclusion Criteria:

• Diagnosis of pancreatic disorders

• Diagnosis of acromegaly

• Diagnosis of GH-related disorders

• Recent bone fractures or immobility before the enrollment (3 months)

• Cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Insulin-like Growth Factor 1
• Sarcopenia

Intervention

Procedure:
• IGF-1 serum value
Evaluation of IGF-1 serum value at baseline, 24 and 48 months

Locations

Country	Name	City	State
Italy	IRCCS Galeazzi	Milan
Italy	Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF-1 reduction in patients with sarcopenia	IGF-1 reduction could be linked to sarcopenia in patients with cognitive impairment	baseline, 24 months, 48 months	No
Secondary	IGF-1 reduction and mortality in patients with cognitive impairment	IGF-1 could be an independent risk factor for mortality in patients with cognitive impairment	baseline, 24 months, 48 months	No