Diabetes Mellitus Type INCT01512030
Prevalence of Peripheral Neuropathy in Children and Adolescents With Type I Diabetes Mellitus: a Prospective Study
An observational study of Diabetes Mellitus Type I and Diabetic Peripheral Neuropathy, run by Landeskrankenhaus Feldkirch at 1 site in Austria.
Trial summary
Diabetes mellitus type I is an increasing burden for more and younger children. Therapy should avoid long-term complications as macrovascular diseases and diabetic nephropathy, retinopathy and diabetic neuropathy (DN). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diabetes Mellitus Type I, Diabetic Peripheral Neuropathy, Nerve Conduction Study Not Performed
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2011to Dec 2015
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents 8 to 18 years suffering from diabetes mellitus type I for more than one year.
Who may be able to join
- 8 to 18 years suffering from diabetes mellitus type I for more than one year.
Who cannot join
- Children who are unable to understand informed consent
- Diabetic children with duration of diabetes < 1 year, age <8 or >18
- Insulin < 0.5IE/kg/d
- Blood glucose before examination below 50 or above 350mg/dL
- Children with chronic diseases, handicapped children, children with cancer, chronic renal impairment, or neurological diseases
- Children who are on medications that can produce peripheral neuropathy, i.e antineoplastic drugs
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dep. of Pediatrics, Academic Teaching Hospital, Landeskrankenhaus Feldkirch
Feldkirch, 6900
About this study
Official title: Prospective Study of Peripherla Neuropathy in Diabetic Type I
Diabetes mellitus type I is an increasing burden for more and younger children. Therapy should avoid long-term complications as macrovascular diseases and diabetic nephropathy, retinopathy and diabetic neuropathy (DN). There is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria. Nerve conduction velocity studies are regarded as the "gold standard" for investigating neuropathies.
We plan a prospective study by investigating the peripheral nerve conduction velocity in a population of diabetic children. At the same time-points, we will do a neurological examination using the Young Score, a clinical score of peripheral neuropathy [10]. The results obtained will be related to other long-term vascular complications (nephropathy, retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of sports/week, and BMI
Read the detailed description
The number of newly diagnosed patients with diabetes mellitus type I increases every year, with the patients becoming younger. The Austrian Diabetes Incidence Study Group demonstrated a significant and constant increase in the incidence rate from 12.0 to 18.4/100,000 in children and adolescents ≤15 years of age from 1999 to 2007 [7]. So, we are confronted with more and more children and adolescents suffering from complications which determine long-term outcome. Chronic disease and complications have an important impact on quality and expectation of life and on health resources.
Among the long-term complications of diabetes, vascular complications including retinopathy, nephropathy, neuropathy, and macrovascular disease are the most prevalent [2]. The main therapeutic goal is to avoid these complications by early detection of clinical or, even better, subclinical signs. For this reason, the International Society for Pediatric and Adolescent Diabetes (ISPAD) periodically issues Clinical Practice Consensus Guidelines, particularly for screening for vascular complications [2]. With regard to diabetic neuropathy (DN) there is still uncertainty about the time frame, intensity and diagnostic method of choice, despite it is a significant source of morbidity and mortality [3]. Additionally, there is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria [4].
The American Academy of Neurology suggests a combination of objective and symptoms, signs and electrophysiology provides the most accurate diagnosis of distal symmetric polyneuropathy [5]. Nerve conduction studies are considered by many as the "gold standard" for nerve damage and the most consistent indicator of (sub-)clinical neuropathy [6].
So far, several cross-sectional studies have been conducted on nerve conduction velocity in diabetic children. The results in regard of prevalence are largely divergent. We found that 15 out of 39 patients (38.5%) had a pathological nerve conduction velocity. This result neither correlated to a clinical symptom score (Young Score which consist of a Neurological Deficiency Score, NDS and a Neuropathy Symptom Score, NSS) [10], nor to mean HbA1c, patients age, duration of diabetes, body mass index, insulin regime, hours of sports or metabolic testing results.
Only one long-term prospective study addressing the issue of the development of diabetic neuropathy in a juvenile population was done so far [8]. To better understand the long term development of diabetic neuropathy we plan to study the peripheral nerve conduction velocity in a population of diabetic children from our outpatient clinic. At the same time, we will do a neurological examination using the Young Score, a clinical score of peripheral neuropathy [10].
The results obtained will be related to other long-term vascular complications (nephropathy, retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of sports/week, and BMI
- Conditions
- Diabetes Mellitus Type I, Diabetic Peripheral Neuropathy, Nerve Conduction Study Not Performed
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the long term development of diabetic neuropathy? Is there a significant deterioration or improvement in nerve conduction during the follow up period?
Measured: 5-years
Secondary outcomes (5)
Correlation to mean HbA1c
Measured: 5 years
mean BMI
Measured: 5 years
Blood pressure
Measured: 5 years
Retinopathy
Measured: 5 years
Nephropathy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landeskrankenhaus Feldkirch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burkhard Simma, Landeskrankenhaus Feldkirch
- Investigators
- Burkhard Simma, MD, Principal investigator, Dep. of Pedaitrics Academic Teaching Hospital, Landeskrankenhaus Feldkirch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512030
- Sponsor's protocol ID
- 02
- Status last verified
- Sep 2016
- First submitted
- 10 Jan 2012
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Peripherla Neuropathy in Diabetic Type I
- ClinicalTrials.gov ID
- NCT01512030
- Acronym / sponsor ID
- 02
- Conditions
- Diabetes Mellitus Type I, Diabetic Peripheral Neuropathy, Nerve Conduction Study Not Performed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Landeskrankenhaus FeldkirchUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jan 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.
Diabetes mellitus type I is an increasing burden for more and younger children. Therapy should avoid long-term complications as macrovascular diseases and diabetic nephropathy, retinopathy and diabetic neuropathy (DN). There is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria. Nerve conduction velocity studies are regarded as the "gold standard" for investigating neuropathies.
We plan a prospective study by investigating the peripheral nerve conduction velocity in a population of diabetic children. At the same time-points, we will do a neurological examination using the Young Score, a clinical score of peripheral neuropathy [10]. The results obtained will be related to other long-term vascular complications (nephropathy, retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of sports/week, and BMI
Detailed description
The number of newly diagnosed patients with diabetes mellitus type I increases every year, with the patients becoming younger. The Austrian Diabetes Incidence Study Group demonstrated a significant and constant increase in the incidence rate from 12.0 to 18.4/100,000 in children and adolescents ≤15 years of age from 1999 to 2007 [7]. So, we are confronted with more and more children and adolescents suffering from complications which determine long-term outcome. Chronic disease and complications have an important impact on quality and expectation of life and on health resources.
Among the long-term complications of diabetes, vascular complications including retinopathy, nephropathy, neuropathy, and macrovascular disease are the most prevalent [2]. The main therapeutic goal is to avoid these complications by early detection of clinical or, even better, subclinical signs. For this reason, the International Society for Pediatric and Adolescent Diabetes (ISPAD) periodically issues Clinical Practice Consensus Guidelines, particularly for screening for vascular complications [2]. With regard to diabetic neuropathy (DN) there is still uncertainty about the time frame, intensity and diagnostic method of choice, despite it is a significant source of morbidity and mortality [3]. Additionally, there is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria [4].
The American Academy of Neurology suggests a combination of objective and symptoms, signs and electrophysiology provides the most accurate diagnosis of distal symmetric polyneuropathy [5]. Nerve conduction studies are considered by many as the "gold standard" for nerve damage and the most consistent indicator of (sub-)clinical neuropathy [6].
So far, several cross-sectional studies have been conducted on nerve conduction velocity in diabetic children. The results in regard of prevalence are largely divergent. We found that 15 out of 39 patients (38.5%) had a pathological nerve conduction velocity. This result neither correlated to a clinical symptom score (Young Score which consist of a Neurological Deficiency Score, NDS and a Neuropathy Symptom Score, NSS) [10], nor to mean HbA1c, patients age, duration of diabetes, body mass index, insulin regime, hours of sports or metabolic testing results.
Only one long-term prospective study addressing the issue of the development of diabetic neuropathy in a juvenile population was done so far [8]. To better understand the long term development of diabetic neuropathy we plan to study the peripheral nerve conduction velocity in a population of diabetic children from our outpatient clinic. At the same time, we will do a neurological examination using the Young Score, a clinical score of peripheral neuropathy [10].
The results obtained will be related to other long-term vascular complications (nephropathy, retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of sports/week, and BMI
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents 8 to 18 years suffering from diabetes mellitus type I for more than one year.
Key inclusion criteria (1 listed)
- 8 to 18 years suffering from diabetes mellitus type I for more than one year.
Key exclusion criteria (6 listed)
- Children who are unable to understand informed consent
- Diabetic children with duration of diabetes < 1 year, age <8 or >18
- Insulin < 0.5IE/kg/d
- Blood glucose before examination below 50 or above 350mg/dL
- Children with chronic diseases, handicapped children, children with cancer, chronic renal impairment, or neurological diseases
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
What is the long term development of diabetic neuropathy? Is there a significant deterioration or improvement in nerve conduction during the follow up period?
Time frame: 5-years
5 secondary outcomes
Correlation to mean HbA1c
Time frame: 5 years
mean BMI
Time frame: 5 years
Blood pressure
Time frame: 5 years
Retinopathy
Time frame: 5 years
Nephropathy
Time frame: 5 years
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 7 Sep 2016.
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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.
Burkhard Simma, MD principal investigator
Dep. of Pedaitrics Academic Teaching Hospital, Landeskrankenhaus Feldkirch
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 Diabetes Mellitus Type I and Diabetic Peripheral Neuropathy, run by Landeskrankenhaus Feldkirch at 1 site in Austria.
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 1 inclusion and 6 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 7 Sep 2016. 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 Austria. 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?
What is the long term development of diabetic neuropathy? Is there a significant deterioration or improvement in nerve conduction during the follow up period? (time frame: 5-years). 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 7 Sep 2016.