Electrodiagnostic Parameters in Patients With Impaired Glucose Tolerance and Diabetes Mellitus

NCT01094418 | Completed

• 1 other identifier: 5-2008-B0001-00099
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance; Peripheral Polyneuropathy; DM

Keywords

polyneuropathy; Nerve conduction study; Impaired glucose tolerance test; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Nerve conduction parameters

  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.

  NCS performed once, within one day after enrollment

Secondary Outcomes (1)

• Clinical neuropathic scoring system

  once, at a single point of time, within one day after enrollment,

Study Arms (3)

IGT group

IGT diagnosed by endocrinologist

Other: Nerve conduction studies ( NCS) of the peripheral nerves

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

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

Interventions

Nerve conduction studies ( NCS) of the peripheral nerves OTHER

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.

Also known as: EMG(Viking )

DM group; IGT group; Normal healthy participants

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University affiliated medical center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Catholic University of Medicine, College of Medicine, Bucheon St. Mary's Hospital, Department of Rehabilitation Medicine

Bucheon-si, Kyoungido, 420-717, South Korea

Location

MeSH Terms

Conditions

Glucose Intolerance; Polyneuropathies; Diabetes Mellitus

Interventions

Zinostatin

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Enediynes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Diynes; Polyynes; Alkynes

Study Officials

• Geun Young Park, MD, PhD

  College of Medicine, Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 29, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 29, 2010

Record last verified: 2010-03

Locations

KR (1)