Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrodiagnostic Parameters in Patients With Impaired Glucose Tolerance and Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01094418
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : March 29, 2010
Sponsor:
Information provided by:
The Catholic University of Korea

Brief Summary:
The purpose of this study is to evaluate the distal sensory nerves of the feet, namely, the dorsal sural, medial dorsal cutaneous and medial plantar nerves, in patients with impaired glucose tolerance and diabetes mellitus type 2 and compare these parameters to those from healthy participants.

Condition or disease Intervention/treatment
Impaired Glucose Tolerance Peripheral Polyneuropathy DM Other: Nerve conduction studies ( NCS) of the peripheral nerves

Detailed Description:

Diabetic Peripheral polyneuropathy (DPP) presents as a slowly progressive primary sensory deficit in length dependent fashion, to result in the classic stocking glove distribution. There is recent evidence to indicate that patients with impaired glucose tolerance ( IGT) on OGTT, the prediabetic stage, have three times the prevalence of distal peripheral polyneuropathy than age matched controls. Patients with IGT, even in their preclinical stages, though they have less severe neuropathy than those with diabetes mellitus, have predominant sensory fiber involvement. To support this, other studies of skin biopsies of IGT patients have shown that microvascular abnormalities and neuropathic changes can occur in the prediabetic stage.

Because DPP is length dependent, it is necessary to evaluate the distal sensory nerves, other than the standard sural and superficial peroneal nerves. To support this theory, recent electrodiagnostic studies in DM patients have shown that albeit normal conduction parameters in the above mentioned two nerves, abnormal parameters can be detected in the more distal sensory nerves, such as the dorsal sural nerve, medial plantar nerves and medial dorsal cutaneous nerve.

Although the importance of evaluating the distal sensory nerves has gained much attention, no study has addressed the issue whether NCS parameters of these distal sensory nerves in IGT patients are significantly different from those of healthy controls with no medical condition, and whether these parameters are different to those with patients with diabetes mellitus, who have no previous history of peripheral polyneuropathy.

With this objective in mind, NCS of the distal sensory nerves of the feet were performed to three groups; normal healthy control group, IGT group and diabetes mellitus group.


Layout table for study information
Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Observational Cross Sectional Study to Evaluate the Sensory Nerve Conduction Parameters of the Distal Sensory Nerves in Patients With Impaired Glucose Tolerance and Diabetes Mellitus
Study Start Date : June 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Group/Cohort Intervention/treatment
IGT group
IGT diagnosed by endocrinologist
Other: Nerve conduction studies ( NCS) of the peripheral nerves

Standard NCS of the sural, superficial peroneal sensory nerves, peroneal, tibial motor nerves, radial and median sensory nerves, median motor nerves, F-wave studies of the Tibial and median nerves.

NCS of the distal sensory nerves; dorsal sural Medial dorsal cutaneous and medial plantar nerves.

Other Name: EMG(Viking )

DM group
DM diagnosed by endocrinologist and whose primary NCS screening shows SNAP amplitudes of sural and superficial peroneal nerves greater than 10mA DM patients with no previous diagnosis of peripheral polyneuropathy
Other: Nerve conduction studies ( NCS) of the peripheral nerves

Standard NCS of the sural, superficial peroneal sensory nerves, peroneal, tibial motor nerves, radial and median sensory nerves, median motor nerves, F-wave studies of the Tibial and median nerves.

NCS of the distal sensory nerves; dorsal sural Medial dorsal cutaneous and medial plantar nerves.

Other Name: EMG(Viking )

Normal healthy participants
Normal health participants with no previous history of DM, IGT, thyroid disorder, hypercholesterolemia, or other condition associated with peripheral polyneuropathy
Other: Nerve conduction studies ( NCS) of the peripheral nerves

Standard NCS of the sural, superficial peroneal sensory nerves, peroneal, tibial motor nerves, radial and median sensory nerves, median motor nerves, F-wave studies of the Tibial and median nerves.

NCS of the distal sensory nerves; dorsal sural Medial dorsal cutaneous and medial plantar nerves.

Other Name: EMG(Viking )




Primary Outcome Measures :
  1. Nerve conduction parameters [ Time Frame: NCS performed once, within one day after enrollment ]
    Nerve conduction study (NCS) parameters of the dorsal sural, medial dorsal cutaneous and medial plantar nerves, along with standard NCS of the tibial and peroenal motor, sural, superficial peronea, median and radial sensory nerves.


Secondary Outcome Measures :
  1. Clinical neuropathic scoring system [ Time Frame: once, at a single point of time, within one day after enrollment, ]
    The Toronoto clinical neuropathic score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
University affiliated medical center
Criteria

Inclusion Criteria:

  • For the normal healthy control group
  • Healthy participants with normal NCS parameters
  • For the IGT group
  • Men or women aged 20-70 with IGT referred by the department of endocrinology, with FBS 100-126 mg/dl, post 2 hour OTT - 140-200mg/dl,lasting more than one year.
  • Patients willing to undergo NCS.
  • For the DM group
  • Men or women aged 20-70 with DM type II patients referred by the department of endocrinology, with no previous diagnosis of peripheral polyneuropathy and who showed SNAP amplitudes of the sural and superficial peroneal nerves above 10mA.
  • Patients willing to undergo NCS.

Exclusion Criteria:

  • No previous diagnosis of any systemic condition related to peripheral polyneuropathy (malnutrition, alcoholic hepatitis, diabetes mellitus( normal group)), no previous medication history, such as chemotherapeutics
  • No symptom or sign of peripheral polyneuropathy, no history of tingling sensation, muscle weakness, or gait disturbance
  • Skin lesion or swelling that would interfere with NCS conduction
  • Previous diagnosis or clinical symptoms that would indicate the presence of mononeuropathy or entrapment neuropathy of the lower extremity.
  • Previous trauma episode of the lower extremity
  • History of alcohol ( exceeding alcohol consumption of 170g per week ) or substance abuse,
  • Pregnancy
  • DM group
  • Presence of undiagnosed peripheral polyneuropathy determined by screening of the sural and superficial peroneal nerves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094418


Locations
Layout table for location information
Korea, Republic of
Catholic University of Medicine, College of Medicine, Bucheon St. Mary's Hospital, Department of Rehabilitation Medicine
Bucheon, Kyoungido, Korea, Republic of, 420-717
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Layout table for investigator information
Principal Investigator: Geun Young Park, MD, PhD College of Medicine, Catholic University of Korea

Layout table for additonal information
Responsible Party: Geun Young Park, M.D., Ph.D.,Assistant Professor, Dept. of Rehabilitation Medicine,Bucheon St. Mary's Hospital,College of Medicine,The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01094418     History of Changes
Other Study ID Numbers: 5-2008-B0001-00099
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010

Keywords provided by The Catholic University of Korea:
polyneuropathy
Nerve conduction study
Impaired glucose tolerance test
Diabetes mellitus

Additional relevant MeSH terms:
Layout table for MeSH terms
Polyneuropathies
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hyperglycemia