Diabetes MellitusNCT00155142
Changes in Skin Innervation of Neurologically Asymptomatic Type 2 Diabetic Patients: the Correlation With the Diabetic Parameters and Neurotrophins.
An observational study of Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To address the following issues: (1) the course of small nerve fiber degeneration in type 2 diabetic patients, especially in asymptomatic patients; (2) the influence of blood sugar control on development of the small fiber degeneration; (3) the correlation of skin innervation with sensory thresholds, autonomic tests… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2004to not given
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) patients fulfilling the diagnosis of type 2 diabetes mellitus19 and receiving oral hyperglycemic agent or insulin treatment with regular follow-up at outpatient clinics, (2) neurologically asymptomatic, i.e. absence of subjective motor or sensory symptom, and absence of motor or sensory sign on neurological examinations, (3) absence of renal impairment or other systemic disease, (4) absence of bleeding tendency, obvious limb edema, poor cardiopulmonary function, acute symptoms of poor diabetic control or any other contraindication for skin biopsy.
Who cannot join
- Use of anti-coagulant; any causes with bleeding tendency; moderate to severe limb edema; history of poor wound healing; poor hygiene and poor care patients; uremia under dialysis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anatomy and Cell Biology, National Taiwan University College of Medicine
Taipei
Sung-Tsang Hsieh, PhD, 886-2-23123456 ext. 8182, sthsieh@ha.mc.ntu.edu.tw
About this study
To address the following issues: (1) the course of small nerve fiber degeneration in type 2 diabetic patients, especially in asymptomatic patients; (2) the influence of blood sugar control on development of the small fiber degeneration; (3) the correlation of skin innervation with sensory thresholds, autonomic tests and parameters of nerve conduction studies; and (4) the role of neurotrophins in diabetic neuropathy, we will perform skin biopsy with quantification of IENF in type 2 diabetic patient without neurological symptoms. The investigations all include clinical evaluation, electrophysiological studies, quantitative sensory test and enzyme linked immunosorbent assay of neurotrophins. The analysis of skin innervation with diabetic parameters will give important insights into the mechanism, prevention and management of small fiber neuropathy in neurologically asymptomatic type 2 diabetic patients, and also therapeutic strategies for diabetic neuropathy.
Read the detailed description
Type 2 diabetes is one of the most common disorders in general population. The overall prevalence of type 2 diabetes among people older than 40 years old in Taiwan is about 10 %. Various complications are associated with diabetes and these complications have become an important issue in daily clinical practice.
Neuropathy is one of the most frequent symptomatic complications of diabetes and is potentially devastating. Small-fiber neuropathy is a major component of diabetic neuropathies and usually causes disabling symptoms like pain and burning. It typically begins at the distal limbs and progresses to the proximal part with time. Recent studies have indicated that skin innervation is reduced in neurologically symptomatic type 2 diabetic patients and the reduction is correlated with the duration of diabetes1. It is not clear whether similar changes occur in neurologically asymptomatic type 2 diabetes. Neurovascular disturbance (i.e. decreased skin blood flow) was noted in early and clinically silent diabetic patients and it might represent the functional and organic abnormalities in small unmyelinated C fibers. Along the same line it is reasonable to speculate that there might be changes in the skin innervation in the preclinical phase of diabetic neuropathic patients. No previous studies have investigated the course of the changes in skin innervation from early or asymptomatic stage to symptomatic stage in diabetic patients.
The relationship of diabetes and the occurrence of peripheral neuropathy had been studied by the Diabetes Control and Complications Trial Research Group and the Kumamoto study in type 1 or 2 diabetes respectively. The results showed that intensive control of hyperglycemia could prevent or delay the development of diabetic neuropathy. However the neuropathies in the studies were assessed by nerve conduction studies. These examinations are insensitive to the small fiber degeneration and it is not clear whether small fibers changes during intensive diabetic control. There is also lack of direct pathogenic evidence regarding the effects of diabetic control on the development of small fiber degeneration.
Neurotrophins are a gene family of structurally related proteins that is released by target tissues of responsive peripheral nerves, binds to specific receptors, and regulates gene expression through the actions of second-messenger systems. Each member of the family has its selectively tropical effects on peripheral nerves and plays a role in promoting neurite outgrowth, inducing morphological differentiation, stimulating expression and release of neurotransmitters and promoting nerve regeneration. It is hypothesized that abnormal availability of neurotrophins is involved in the pathogenesis of diabetic neuropathy. Studies have showed reduced seral level of neurotrophins in diabetic patients but it is not clear whether the impact of this finding on the diabetic neuropathy. There have no studies demonstrating if nay correlation between abnormal neurotrophins expression and the pathogenesis of small fiber neuropathy in diabetic patients.
Skin biopsy with quantification of intraepidermal nerve fibers (IENF) is a new pathological approach to study small fiber sensory neuropathy. By applying this technique with enzyme linked immunosorbent assay, we will clarify the following issues:
- Changes in skin innervation of neurologically asymptomatic type 2 diabetic patient.
- The influence of diabetic control on the development of small fiber neuropathy.
- The effect of neurotrophins on the pathogenesis of small fiber neuropathy.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung-Tsang Hsieh, PhD, Study director, Department of Anatomy and Cell Biology, National Taiwan University College of Medicine; Department of Neurology, National Taiwan University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155142
- Sponsor's protocol ID
- 9361701104
- Status last verified
- Sep 2004
- First submitted
- 9 Sep 2005
- Last updated
- 28 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Skin Innervation of Neurologically Asymptomatic Type 2 Diabetic Patients: the Correlation With the Diabetic Parameters and Neurotrophins.
- ClinicalTrials.gov ID
- NCT00155142
- Acronym / sponsor ID
- 9361701104
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 12 Sep 2005 (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.
To address the following issues: (1) the course of small nerve fiber degeneration in type 2 diabetic patients, especially in asymptomatic patients; (2) the influence of blood sugar control on development of the small fiber degeneration; (3) the correlation of skin innervation with sensory thresholds, autonomic tests and parameters of nerve conduction studies; and (4) the role of neurotrophins in diabetic neuropathy, we will perform skin biopsy with quantification of IENF in type 2 diabetic patient without neurological symptoms. The investigations all include clinical evaluation, electrophysiological studies, quantitative sensory test and enzyme linked immunosorbent assay of neurotrophins. The analysis of skin innervation with diabetic parameters will give important insights into the mechanism, prevention and management of small fiber neuropathy in neurologically asymptomatic type 2 diabetic patients, and also therapeutic strategies for diabetic neuropathy.
Detailed description
Type 2 diabetes is one of the most common disorders in general population. The overall prevalence of type 2 diabetes among people older than 40 years old in Taiwan is about 10 %. Various complications are associated with diabetes and these complications have become an important issue in daily clinical practice.
Neuropathy is one of the most frequent symptomatic complications of diabetes and is potentially devastating. Small-fiber neuropathy is a major component of diabetic neuropathies and usually causes disabling symptoms like pain and burning. It typically begins at the distal limbs and progresses to the proximal part with time. Recent studies have indicated that skin innervation is reduced in neurologically symptomatic type 2 diabetic patients and the reduction is correlated with the duration of diabetes1. It is not clear whether similar changes occur in neurologically asymptomatic type 2 diabetes. Neurovascular disturbance (i.e. decreased skin blood flow) was noted in early and clinically silent diabetic patients and it might represent the functional and organic abnormalities in small unmyelinated C fibers. Along the same line it is reasonable to speculate that there might be changes in the skin innervation in the preclinical phase of diabetic neuropathic patients. No previous studies have investigated the course of the changes in skin innervation from early or asymptomatic stage to symptomatic stage in diabetic patients.
The relationship of diabetes and the occurrence of peripheral neuropathy had been studied by the Diabetes Control and Complications Trial Research Group and the Kumamoto study in type 1 or 2 diabetes respectively. The results showed that intensive control of hyperglycemia could prevent or delay the development of diabetic neuropathy. However the neuropathies in the studies were assessed by nerve conduction studies. These examinations are insensitive to the small fiber degeneration and it is not clear whether small fibers changes during intensive diabetic control. There is also lack of direct pathogenic evidence regarding the effects of diabetic control on the development of small fiber degeneration.
Neurotrophins are a gene family of structurally related proteins that is released by target tissues of responsive peripheral nerves, binds to specific receptors, and regulates gene expression through the actions of second-messenger systems. Each member of the family has its selectively tropical effects on peripheral nerves and plays a role in promoting neurite outgrowth, inducing morphological differentiation, stimulating expression and release of neurotransmitters and promoting nerve regeneration. It is hypothesized that abnormal availability of neurotrophins is involved in the pathogenesis of diabetic neuropathy. Studies have showed reduced seral level of neurotrophins in diabetic patients but it is not clear whether the impact of this finding on the diabetic neuropathy. There have no studies demonstrating if nay correlation between abnormal neurotrophins expression and the pathogenesis of small fiber neuropathy in diabetic patients.
Skin biopsy with quantification of intraepidermal nerve fibers (IENF) is a new pathological approach to study small fiber sensory neuropathy. By applying this technique with enzyme linked immunosorbent assay, we will clarify the following issues:
- Changes in skin innervation of neurologically asymptomatic type 2 diabetic patient.
- The influence of diabetic control on the development of small fiber neuropathy.
- The effect of neurotrophins on the pathogenesis of small fiber neuropathy.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1) patients fulfilling the diagnosis of type 2 diabetes mellitus19 and receiving oral hyperglycemic agent or insulin treatment with regular follow-up at outpatient clinics, (2) neurologically asymptomatic, i.e. absence of subjective motor or sensory symptom, and absence of motor or sensory sign on neurological examinations, (3) absence of renal impairment or other systemic disease, (4) absence of bleeding tendency, obvious limb edema, poor cardiopulmonary function, acute symptoms of poor diabetic control or any other contraindication for skin biopsy.
Key exclusion criteria (1 listed)
- Use of anti-coagulant; any causes with bleeding tendency; moderate to severe limb edema; history of poor wound healing; poor hygiene and poor care patients; uremia under dialysis.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2005.
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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.
Sung-Tsang Hsieh, PhD study director
Department of Anatomy and Cell Biology, National Taiwan University College of Medicine; Department of Neurology, National Taiwan University Hospital.
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, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 28 Nov 2005. 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 Taiwan. 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 Sung-Tsang Hsieh, PhD (886-2-23123456 ext. 8182, sthsieh@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 28 Nov 2005.