Subclinical Neuropathy Among Diabetes Control and Complications Trial Participants Without Diagnosable Neuropathy at Trial Completion
Possible predictors of incident neuropathy?
- James W. Albers, MD, PHD,
- William H. Herman, MD, MPH,
- Rodica Pop-Busui, MD, PHD,
- Catherine L. Martin, MS,
- Patricia Cleary, MS,
- Barbara Waberski, MS and
- for the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Intervention and Complications (EDIC) Research Group*
- From the Diabetes Control and Complications Trial/Epidemiology of Diabetes Intervention and Complications Research Group, Bethesda, Maryland
- Address correspondence and reprint requests to James W. Albers, MD, PhD, DCCT/EDIC Research Group, Box DCCT/EDIC, Bethesda, MD 20892. E-mail: jwalbers{at}umich.edu
Abstract
OBJECTIVE—We sought to evaluate the prevalence of subclinical neuropathy in intensive and conventional treatment groups at completion of the Diabetes Control and Complications Trial (DCCT).
RESEARCH DESIGN AND METHODS—We assessed neuropathy using nerve conduction results obtained at DCCT completion after stratifying the DCCT cohort to exclude subjects with progressively less severe degrees of diagnosable neuropathy. We began with those who had confirmed clinical neuropathy (the primary DCCT end point) and eventually excluded all subjects with any clinical or electrodiagnostic evidence of neuropathy.
RESULTS—After excluding subjects with confirmed clinical neuropathy at DCCT completion, 8 of 10 nerve conduction measures (including all lower-extremity measures) were significantly improved in the intensive treatment group (O'Brien rank-sum test across all nerve conduction measures, P < 0.0001). Conduction velocity group differences were substantial, and the peroneal conduction velocity averaged 3.1 m/s faster in the intensive compared with the conventional treatment group (45.1 vs. 42.0 m/s, P < 0.0001). Numerous significant differences in median and peroneal motor conduction velocities favoring the intensive treatment group persisted, regardless of the exclusion criteria applied.
CONCLUSIONS—Intensive and conventional treatment group subjects without diagnosable neuropathy at DCCT completion had significant differences in electrophysiologic measurements favoring the intensive treatment group. Differences in subsequent incident neuropathy between the original treatment groups may reflect, in part, their levels of subclinical neuropathy at DCCT completion, rather than persistent metabolic effects.
- DCCT, Diabetes Control and Complications Trial
- EDIC, Epidemiology of Diabetes Intervention and Complications
Footnotes
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Published ahead of print at http://care.diabetesjournals.org on 20 July 2007. DOI: 10.2337/dc07-0850. Clinical trial reg. no. NCT00360893, clinicaltrials.gov.
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↵* A complete list of investigators and members of the Diabetes Control and Complications Trial (DCCT)/ Epidemiology of Diabetes Intervention and Complications (EDIC) Research Group appears in refs. 1 and 15.
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J.W.A. has received personal compensation from Eli Lilly for consulting and serving on a data monitoring committee, from Wyeth Research for serving on a safety monitoring committee, and from Prana Biotechnology for consulting and has received research funding from the National Institutes of Health.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
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- Accepted July 13, 2007.
- Received May 2, 2007.
- DIABETES CARE
