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

NCT02139410 | Completed DMC

• 1 other identifier: IGF-001
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cognitive Impairment; Insulin-like Growth Factor 1

Keywords

sarcopenia; mortality

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• IGF-1 reduction and mortality in patients with cognitive impairment

  baseline, 24 months, 48 months

Study Arms (2)

IGF-1 1st and 2nd quartile

Reduction of IGF-1 serum value in a cohort of patients with cognitive impairment

Procedure: IGF-1 serum value

IGF-1 3rd and 4rd quartile

Reduction of IGF-1 serum value in a cohort of patients with cognitive impairment

Procedure: IGF-1 serum value

Interventions

IGF-1 serum value PROCEDURE

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

IGF-1 1st and 2nd quartile; IGF-1 3rd and 4rd quartile

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients were enrolled from orthopedics clinic (IRCCS Galeazzi Milan) and geriatric day service (Sapienza University of Rome)

You may qualify if:

• Diagnosis of cognitive impairment (MMSE \< 24)
• Age \> 65 ys

You may not qualify if:

• Diagnosis of pancreatic disorders
• Diagnosis of acromegaly
• Diagnosis of GH-related disorders
• Recent bone fractures or immobility before the enrollment (3 months)
• Cancer

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

IRCCS Galeazzi

Milan, Italy, Italy

Location

Sapienza University of Rome

Rome, Italy, 00161, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sarcopenia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Vincenzo Gianturco, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: June 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 15, 2014

Record last verified: 2013-09

Locations

IT (2)