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

May 13, 2014 updated by: Vincenzo Gianturco, University of Roma La Sapienza

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

589

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • IRCCS Galeazzi
      • Rome, Italy, 00161
        • Sapienza University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 24 months, 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 24 months, 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Vincenzo Gianturco, MD, University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (ESTIMATE)

May 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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