Cognitive ImpairmentISAACNCT02139410
IGF-1, Sarcopenia and Mortality: a Cohort Study in Patient With Cognitive Impairment
An observational study of Cognitive Impairment and Insulin-like Growth Factor 1, run by University of Roma La Sapienza at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Cognitive Impairment, Insulin-like Growth Factor 1
- What is being tested?
- IGF-1 serum value
- Type of treatment
- Surgery or procedure
- How many people
- 589 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2008to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Consecutive patients were enrolled from orthopedics clinic (IRCCS Galeazzi Milan) and geriatric day service (Sapienza University of Rome)
Who may be able to join
- Diagnosis of cognitive impairment (MMSE < 24)
- Age > 65 ys
Who cannot join
- Diagnosis of pancreatic disorders
- Diagnosis of acromegaly
- Diagnosis of GH-related disorders
- Recent bone fractures or immobility before the enrollment (3 months)
- Cancer
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Galeazzi
Milan, Italy
Sapienza University of Rome
Rome, Italy, 00161
About this study
Official title: 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.
- Conditions
- Cognitive Impairment, Insulin-like Growth Factor 1
- Being tested
- IGF-1 serum value
- Keywords
- sarcopenia, mortality
- Medical subject headings
- Cognitive Dysfunction, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGF-1 serum valueProcedure or surgery
Evaluation of IGF-1 serum value at baseline, 24 and 48 months
| Study group | Role | What they receive |
|---|---|---|
| IGF-1 1st and 2nd quartile | Reduction of IGF-1 serum value in a cohort of patients with cognitive impairment Receives: 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 Receives: Procedure: IGF-1 serum value |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 reduction in patients with sarcopenia
IGF-1 reduction could be linked to sarcopenia in patients with cognitive impairment
Measured: baseline, 24 months, 48 months
Secondary outcomes (1)
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
Measured: baseline, 24 months, 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJun 2008
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Gianturco, University of Roma La Sapienza
- Investigators
- Vincenzo Gianturco, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139410
- Sponsor's protocol ID
- IGF-001
- Acronym
- ISAAC
- Status last verified
- Sep 2013
- First submitted
- 13 May 2014
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Like Growth Factor 1 and Risks of Sarcopenia and Mortality in Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02139410
- Acronym / sponsor ID
- ISAAC / IGF-001
- Conditions
- Cognitive Impairment, Insulin-like Growth Factor 1
- Keywords
- sarcopenia, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGF-1 1st and 2nd quartile | – | Procedure: IGF-1 serum valueReduction of IGF-1 serum value in a cohort of patients with cognitive impairment |
| IGF-1 3rd and 4rd quartile | – | Procedure: IGF-1 serum valueReduction of IGF-1 serum value in a cohort of patients with cognitive impairment |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Consecutive patients were enrolled from orthopedics clinic (IRCCS Galeazzi Milan) and geriatric day service (Sapienza University of Rome)
Key inclusion criteria (2 listed)
- Diagnosis of cognitive impairment (MMSE < 24)
- Age > 65 ys
Key exclusion criteria (5 listed)
- Diagnosis of pancreatic disorders
- Diagnosis of acromegaly
- Diagnosis of GH-related disorders
- Recent bone fractures or immobility before the enrollment (3 months)
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGF-1 serum valueEvaluation of IGF-1 serum value at baseline, 24 and 48 months | Procedure or surgery | IGF-1 1st and 2nd quartile, IGF-1 3rd and 4rd quartile |
Primary outcome
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
1 secondary outcome
IGF-1 reduction and mortality in patients with cognitive impairment
Time frame: baseline, 24 months, 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Gianturco, MD principal investigator
University of Roma La Sapienza
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Insulin-like Growth Factor 1, run by University of Roma La Sapienza at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF-1 reduction in patients with sarcopenia (time frame: baseline, 24 months, 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.