Type 1 Diabetes MellitusNCT01017718
Nerve Conduction Velocity in Diabetic Children
An observational study of Type 1 Diabetes Mellitus, run by Landeskrankenhaus Feldkirch at 1 site in Austria.
Trial summary
The investigators intend to study children and adolescents from 8 to 18 years suffering from diabetes mellitus type 1 for more than one year. The patients will undergo a detailed clinical examination for anthropometric data, blood pressure, blood and urine. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- May 2009to Jul 2011
- 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 with diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d)
Who may be able to join
- Children and adolescents with diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d)
Who cannot join
- No consent
- Diabetic children with duration of diabetes < 1 year, age <8 or >18 year or insulin requirement > 0.5 IU/kg/d
- Blood glucose levels <50 or >350 mg/dl
- Children with chronic diseases, handicapped children, children with cancer, chronic renal impairment, or neurological diseases
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pediatrics, University Teaching Hospital, Landeskrankenhaus Feldkirch
Feldkirch, 6800
About this study
Official title: Prevalence of Pathological Nerve Conduction Velocity in Children and Adolescents Suffering From Diabetes Mellitus Type I
The investigators intend to study children and adolescents from 8 to 18 years suffering from diabetes mellitus type 1 for more than one year. The patients will undergo a detailed clinical examination for anthropometric data, blood pressure, blood and urine. Motor and sensory nerve conduction velocity will be examined by electrical stimulation using surface patch electrodes. The nerves to be examined are the nervus tibialis anterior, nervus medianus and nervus peroneus.
Primary outcome:
Read more
How many children and adolescents suffering from diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve conduction velocity?
Secondary outcome:
Is there a significant difference in nerve conduction velocity between the group of diabetic patients and the control group of healthy young people? Does the quality of disease control have an influence on nerve conduction velocity? Is there a correlation between nerve conduction velocity in our study patients and the Young Score? Is there a correlation between pathological nerve conduction velocity and other long-term vascular complications (nephropathy, retinopathy)?
Read the detailed description
Diabetes mellitus type 1 is a chronic disease in which the pancreas no longer produces enough insulin and the glucose in the blood cannot be absorbed into the cells of the body. The main symptom is hyperglycemia. After 10 to 15 years of disease long-term vascular complications including retinopathy, nephropathy, neuropathy, and macrovascular disease are seen. Among the most common long-term complications of diabetes, diabetic neuropathy (DN) is a significant source of morbidity and mortality. There is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria with data variation ranging from 5% to 100%. DN is thought to result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum). It is a set of heterogeneous clinical syndromes that affect distinct regions of the nervous system, individually or combined. The investigators differentiate autonomic and peripheral neuropathy: Clinical presentation of autonomic neuropathy includes postural hypotension, vomiting, diarrhea, bladder paresis, impotence, sweating abnormalities, and gastric fullness. Peripheral neuropathy presents as altered pain sensations (dys-, para-, hypo- or hyperesthesia), burning, and either superficial or deep pain. The examination of choice for the diagnosis of peripheral neuropathy is to determine nerve conduction velocity.
One of the main goals in treating children and adolescents suffering from diabetes mellitus type I is to avoid long-term 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. With regard to DN there is still uncertainty about the time frame, intensity and diagnostic method of choice.
The investigators aim to examine children and adolescents from 8 to 18 years suffering from diabetes mellitus type I for more than one year with an insulin requirement of more than 0.5 IU/kg/d. The investigators will exclude children with other chronic diseases, handicapped children or children suffering from cancer or chronic renal impairment, as well as children with other neurological diseases which can also cause a change in nerve conduction velocity, and children with blood glucose levels below 50 or above 350 mg/dl. At the time of the annual check-up the patients will undergo a detailed examination for anthropometric data, blood pressure, blood and urine. Thereafter, motor and sensory nerve conduction velocity will be determined by electrical stimulation using surface patch electrodes. The nerves to be investigated are the nervus tibialis anterior, nervus medianus and nervus peroneus. Finally, the patient will undergo a neurological investigation to calculate his Young Score (Neuropathy Symptom Score).
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes mellitus type I, nerve conduction velocity, Young score, long term vascular complications
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
How many children and adolescents suffering from diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve conduction velocity?
Measured: One electrophysiological investigation (nerve conduction velocity)
Secondary outcomes (1)
Is there a correlation between nerve conduction velocity in our study patients and the Young Score?
Measured: One clinical investigation (Young score)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- 40 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, Prof, Principal investigator, Landeskrankenhaus Feldkirch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017718
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2011
- First submitted
- 20 Nov 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trotta D, Verrotti A, Salladini C, Chiarelli F. Diabetic neuropathy in children and adolescents. Pediatr Diabetes. 2004 Mar;5(1):44-57. doi: 10.1111/j.1399-543X.2004.00041.x.
PubMed 15043690dos Santos LH, Bruck I, Antoniuk SA, Sandrini R. Evaluation of sensorimotor polyneuropathy in children and adolescents with type I diabetes: associations with microalbuminuria and retinopathy. Pediatr Diabetes. 2002 Jun;3(2):101-8. doi: 10.1034/j.1399-5448.2002.30207.x.
PubMed 15016164Nelson D, Mah JK, Adams C, Hui S, Crawford S, Darwish H, Stephure D, Pacaud D. Comparison of conventional and non-invasive techniques for the early identification of diabetic neuropathy in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2006 Dec;7(6):305-10. doi: 10.1111/j.1399-5448.2006.00208.x.
PubMed 17212597Meh D, Denislic M. Subclinical neuropathy in type I diabetic children. Electroencephalogr Clin Neurophysiol. 1998 Jun;109(3):274-80. doi: 10.1016/s0924-980x(98)00017-4.
PubMed 9741795Hyllienmark L, Brismar T, Ludvigsson J. Subclinical nerve dysfunction in children and adolescents with IDDM. Diabetologia. 1995 Jun;38(6):685-92. doi: 10.1007/BF00401840.
PubMed 7672490Dorchy H, Noel P, Kruger M, de Maertelaer V, Dupont E, Toussaint D, Pelc S. Peroneal motor nerve conduction velocity in diabetic children and adolescents. Relationships to metabolic control, HLA-DR antigens, retinopathy, and EEG. Eur J Pediatr. 1985 Nov;144(4):310-5. doi: 10.1007/BF00441770.
PubMed 3865772
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pathological Nerve Conduction Velocity in Children and Adolescents Suffering From Diabetes Mellitus Type I
- ClinicalTrials.gov ID
- NCT01017718
- Acronym / sponsor ID
- 01
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes mellitus type I, nerve conduction velocity, Young score, long term vascular complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Landeskrankenhaus FeldkirchUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Nov 2009 (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.
The investigators intend to study children and adolescents from 8 to 18 years suffering from diabetes mellitus type 1 for more than one year. The patients will undergo a detailed clinical examination for anthropometric data, blood pressure, blood and urine. Motor and sensory nerve conduction velocity will be examined by electrical stimulation using surface patch electrodes. The nerves to be examined are the nervus tibialis anterior, nervus medianus and nervus peroneus.
Primary outcome:
How many children and adolescents suffering from diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve conduction velocity?
Secondary outcome:
Is there a significant difference in nerve conduction velocity between the group of diabetic patients and the control group of healthy young people? Does the quality of disease control have an influence on nerve conduction velocity? Is there a correlation between nerve conduction velocity in our study patients and the Young Score? Is there a correlation between pathological nerve conduction velocity and other long-term vascular complications (nephropathy, retinopathy)?
Detailed description
Diabetes mellitus type 1 is a chronic disease in which the pancreas no longer produces enough insulin and the glucose in the blood cannot be absorbed into the cells of the body. The main symptom is hyperglycemia. After 10 to 15 years of disease long-term vascular complications including retinopathy, nephropathy, neuropathy, and macrovascular disease are seen. Among the most common long-term complications of diabetes, diabetic neuropathy (DN) is a significant source of morbidity and mortality. There is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria with data variation ranging from 5% to 100%. DN is thought to result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum). It is a set of heterogeneous clinical syndromes that affect distinct regions of the nervous system, individually or combined. The investigators differentiate autonomic and peripheral neuropathy: Clinical presentation of autonomic neuropathy includes postural hypotension, vomiting, diarrhea, bladder paresis, impotence, sweating abnormalities, and gastric fullness. Peripheral neuropathy presents as altered pain sensations (dys-, para-, hypo- or hyperesthesia), burning, and either superficial or deep pain. The examination of choice for the diagnosis of peripheral neuropathy is to determine nerve conduction velocity.
One of the main goals in treating children and adolescents suffering from diabetes mellitus type I is to avoid long-term 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. With regard to DN there is still uncertainty about the time frame, intensity and diagnostic method of choice.
The investigators aim to examine children and adolescents from 8 to 18 years suffering from diabetes mellitus type I for more than one year with an insulin requirement of more than 0.5 IU/kg/d. The investigators will exclude children with other chronic diseases, handicapped children or children suffering from cancer or chronic renal impairment, as well as children with other neurological diseases which can also cause a change in nerve conduction velocity, and children with blood glucose levels below 50 or above 350 mg/dl. At the time of the annual check-up the patients will undergo a detailed examination for anthropometric data, blood pressure, blood and urine. Thereafter, motor and sensory nerve conduction velocity will be determined by electrical stimulation using surface patch electrodes. The nerves to be investigated are the nervus tibialis anterior, nervus medianus and nervus peroneus. Finally, the patient will undergo a neurological investigation to calculate his Young Score (Neuropathy Symptom Score).
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 with diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d)
Key inclusion criteria (1 listed)
- Children and adolescents with diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d)
Key exclusion criteria (4 listed)
- No consent
- Diabetic children with duration of diabetes < 1 year, age <8 or >18 year or insulin requirement > 0.5 IU/kg/d
- Blood glucose levels <50 or >350 mg/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
How many children and adolescents suffering from diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve conduction velocity?
Time frame: One electrophysiological investigation (nerve conduction velocity)
1 secondary outcome
Is there a correlation between nerve conduction velocity in our study patients and the Young Score?
Time frame: One clinical investigation (Young score)
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 27 Sep 2011.
- Background: PubMed 15043690Trotta D, Verrotti A, Salladini C, Chiarelli F. Diabetic neuropathy in children and adolescents. Pediatr Diabetes. 2004 Mar;5(1):44-57. doi: 10.1111/j.1399-543X.2004.00041.x.
- Background: PubMed 15016164dos Santos LH, Bruck I, Antoniuk SA, Sandrini R. Evaluation of sensorimotor polyneuropathy in children and adolescents with type I diabetes: associations with microalbuminuria and retinopathy. Pediatr Diabetes. 2002 Jun;3(2):101-8. doi: 10.1034/j.1399-5448.2002.30207.x.
- Background: PubMed 17212597Nelson D, Mah JK, Adams C, Hui S, Crawford S, Darwish H, Stephure D, Pacaud D. Comparison of conventional and non-invasive techniques for the early identification of diabetic neuropathy in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2006 Dec;7(6):305-10. doi: 10.1111/j.1399-5448.2006.00208.x.
- Background: PubMed 9741795Meh D, Denislic M. Subclinical neuropathy in type I diabetic children. Electroencephalogr Clin Neurophysiol. 1998 Jun;109(3):274-80. doi: 10.1016/s0924-980x(98)00017-4.
- Background: PubMed 7672490Hyllienmark L, Brismar T, Ludvigsson J. Subclinical nerve dysfunction in children and adolescents with IDDM. Diabetologia. 1995 Jun;38(6):685-92. doi: 10.1007/BF00401840.
- Background: PubMed 3865772Dorchy H, Noel P, Kruger M, de Maertelaer V, Dupont E, Toussaint D, Pelc S. Peroneal motor nerve conduction velocity in diabetic children and adolescents. Relationships to metabolic control, HLA-DR antigens, retinopathy, and EEG. Eur J Pediatr. 1985 Nov;144(4):310-5. doi: 10.1007/BF00441770.
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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, Prof principal investigator
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 Type 1 Diabetes Mellitus, 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 4 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 27 Sep 2011. 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?
How many children and adolescents suffering from diabetes mellitus type 1 (duration of disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve conduction velocity? (time frame: One electrophysiological investigation (nerve conduction velocity)). 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 NCT01017718, which also lists 6 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 27 Sep 2011.