Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139410
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Vincenzo Gianturco, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment
Cognitive Impairment Insulin-like Growth Factor 1 Procedure: IGF-1 serum value

Layout table for study information
Study Type : Observational
Actual Enrollment : 589 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insulin Like Growth Factor 1 and Risks of Sarcopenia and Mortality in Patients With Cognitive Impairment
Study Start Date : June 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Evaluation of IGF-1 serum value at baseline, 24 and 48 months

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




Primary Outcome Measures :
  1. IGF-1 reduction in patients with sarcopenia [ Time Frame: baseline, 24 months, 48 months ]
    IGF-1 reduction could be linked to sarcopenia in patients with cognitive impairment


Secondary Outcome Measures :
  1. IGF-1 reduction and mortality in patients with cognitive impairment [ Time Frame: baseline, 24 months, 48 months ]
    IGF-1 could be an independent risk factor for mortality in patients with cognitive impairment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139410


Locations
Layout table for location information
Italy
IRCCS Galeazzi
Milan, Italy
Sapienza University of Rome
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Layout table for investigator information
Principal Investigator: Vincenzo Gianturco, MD Sapienza University of Rome
Layout table for additonal information
Responsible Party: Vincenzo Gianturco, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02139410    
Other Study ID Numbers: IGF-001
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: September 2013
Keywords provided by Vincenzo Gianturco, University of Roma La Sapienza:
sarcopenia
mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical