Insulin-like Growth Factor INCT01718015
Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
An observational study of Insulin-like Growth Factor I and Insulin-like Growth Factor II, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP) remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin-like Growth Factor I, Insulin-like Growth Factor II, Diabetes Complications
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Aug 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have performed a lumbar puncture at Department of Neurology and Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark.
Who may be able to join
- Patients with diabetic polyneuropathy
- Patients with diabetes without peripheral nerve disorder
- Patients with polyneuropathies not due to diabetes
- Patients not suffering from diabetes or nerve disease (control subjects)
- Patients with unspecified nerve disease
Who cannot join
- Other causes to the development of polyneuropathy in patients with diabetic polyneuropathy
- Cerebral infections
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, 8000
Henning Andersen, Professor, MD Phd, hennande@rm.dk
Henning Andersen, Professor, MD Phd
About this study
Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP) remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism. The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for development and regeneration of the nervous system. In earlier studies reduced concentrations of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin biopsies have been found in patients with DP.
Purpose: Our purpose is to determine the concentration and biological activity of Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163 (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy control subjects. We will furthermore relate the findings to peripheral nerve function. In addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.
Read more
Hypothesis: We hypothesize that DP develops due to reduced concentration and biological activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients without damage to the nervous system and healthy control subjects.
Methods: Study subjects consists of patients from Department of Neurology and Department of Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark, who are having a lumbar puncture performed.
- Conditions
- Insulin-like Growth Factor I, Insulin-like Growth Factor II, Diabetes Complications, Polyneuropathies, Nerve Growth Factors
- Keywords
- Vascular Endothelial Growth Factor, Brain-Derived Neurothropic Factor, Diabetes Mellitus, CD-163, Cerebrospinal fluid, Peripheral Nervous System Diseases, Mass spectrometry
- Medical subject headings
- Diabetes Complications, Polyneuropathies, Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetic polyneuropathy | Not described | |
| Patients with diabetes without peripheral nerve disorder | Not described | |
| Patients with polyneuropathies not due to diabetes | Not described | |
| Patients not suffering from diabetes or nerve disease | Control subjects | |
| Patients with unspecified nerve disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.
Measured: november 2012 - august 2013
Secondary outcomes (4)
Clinical neurological examination including tendon reflexes, muscle strength and sensation.
Measured: november 2012 - august 2013
Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity)
Measured: november 2012 - august 2013
Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg)
Measured: november 2012 - august 2013
Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg)
Measured: November 2012 - august 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insulin-like Growth Factor IStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
- Responsible party
- Principal investigator, Mia Jørgensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718015
- Sponsor's protocol ID
- 1-10-72-470-12.
- Other IDs
- 1-16-02-272-12
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andreassen CS, Jakobsen J, Flyvbjerg A, Andersen H. Expression of neurotrophic factors in diabetic muscle--relation to neuropathy and muscle strength. Brain. 2009 Oct;132(Pt 10):2724-33. doi: 10.1093/brain/awp208. Epub 2009 Aug 20.
PubMed 19696031Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
PubMed 22271730Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226.
PubMed 21695763
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy
- ClinicalTrials.gov ID
- NCT01718015
- Acronym / sponsor ID
- 1-10-72-470-12.
- Conditions
- Insulin-like Growth Factor I, Insulin-like Growth Factor II, Diabetes Complications, Polyneuropathies, Nerve Growth Factors
- Keywords
- Vascular Endothelial Growth Factor, Brain-Derived Neurothropic Factor, Diabetes Mellitus, CD-163, Cerebrospinal fluid, Peripheral Nervous System Diseases, Mass spectrometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Laboratory for Proteome Analysis and Protein Characterization, Aarhus University
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 31 Oct 2012 (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.
Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP) remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism. The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for development and regeneration of the nervous system. In earlier studies reduced concentrations of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin biopsies have been found in patients with DP.
Purpose: Our purpose is to determine the concentration and biological activity of Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163 (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy control subjects. We will furthermore relate the findings to peripheral nerve function. In addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.
Hypothesis: We hypothesize that DP develops due to reduced concentration and biological activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients without damage to the nervous system and healthy control subjects.
Methods: Study subjects consists of patients from Department of Neurology and Department of Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark, who are having a lumbar puncture performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetic polyneuropathy | – | – |
| Patients with diabetes without peripheral nerve disorder | – | – |
| Patients with polyneuropathies not due to diabetes | – | – |
| Patients not suffering from diabetes or nerve disease | – | –Control subjects |
| Patients with unspecified nerve disease | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have performed a lumbar puncture at Department of Neurology and Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark.
Key inclusion criteria (5 listed)
- Patients with diabetic polyneuropathy
- Patients with diabetes without peripheral nerve disorder
- Patients with polyneuropathies not due to diabetes
- Patients not suffering from diabetes or nerve disease (control subjects)
- Patients with unspecified nerve disease
Key exclusion criteria (2 listed)
- Other causes to the development of polyneuropathy in patients with diabetic polyneuropathy
- Cerebral infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.
Time frame: november 2012 - august 2013
4 secondary outcomes
Clinical neurological examination including tendon reflexes, muscle strength and sensation.
Time frame: november 2012 - august 2013
Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity)
Time frame: november 2012 - august 2013
Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg)
Time frame: november 2012 - august 2013
Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg)
Time frame: November 2012 - august 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- Background: PubMed 19696031Andreassen CS, Jakobsen J, Flyvbjerg A, Andersen H. Expression of neurotrophic factors in diabetic muscle--relation to neuropathy and muscle strength. Brain. 2009 Oct;132(Pt 10):2724-33. doi: 10.1093/brain/awp208. Epub 2009 Aug 20.
- Background: PubMed 22271730Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
- Background: PubMed 21695763Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin-like Growth Factor I and Insulin-like Growth Factor II, run by Aarhus University Hospital at 1 site in Denmark.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mia Jørgensen, medical research year student (9194 4232 ext. +45, mia.jorgensen@studmed.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood. (time frame: november 2012 - august 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718015, which also lists 3 linked publications.
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 31 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.