NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000615

Registered date:20/02/2007

Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedDiabetic peripheral neuropathy
Date of first enrollment1997/04/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Epalrestat(50mg) was orally administered three times daily before each meal (150 mg/day) with conventional therapies Conventional therapy (diet treatment, hypoglycemic agents, insulin, and hypotensive agents)

Outcome(s)

Primary OutcomeChange from baseline in median MNCV at 3 years
Secondary OutcomeOther somatic nerve function parameters (minimum F-wave latency [MFWL] of the median motor nerve and vibration perception threshold [VPT]), cardiovascular autonomic nerve function and subjective symptoms

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteriaAdults aged =>20 years were diagnosed in each facilities as mild diabetic peripheral neuropathy based on subjective symptoms, no foot ulcer and neurological dysfunctions (at least two parameters; MNCV [indispensable] and VPT or Achilles tendon reflex, etc.). Patients were enrolled for study if they had a median motor nerve conduction velocity (MNCV) =>40 m/s (seemingly reversible) and stable glycemic control (HbA1c <=9%, with +/- 0.5% variation in the previous 3 months).
Exclude criteriaSubjects were excluded if their primary cause of neurologic disorder was not diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease, etc.), if they had arteriosclerosis obliterans (ankle brachial pressure index of <=0.8), or severe hepatic or renal disorder, if they were participating in other interventional studies, or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.

Related Information

Contact

public contact
Name Nigishi Hotta
Address Japan
Telephone
E-mail hotta@chubuh.rofuku.go.jp
Affiliation Japan Labour Health and Welfare Organization CHUBU ROSAI HOSPITAL Director General
scientific contact
Name Yukio Shigeta
Address Seta Tsukinowa-cho, Otsu,Shiga 520-2192 JAPAN Japan
Telephone
E-mail
Affiliation Shiga University of Medical Science, Otsu, Japan Professors Emeritus