Long Term Effects of Diet and Exercise on Early Diabetic Neuropathy

描述 2型糖尿病是一个日益严重的问题，在人口老龄化，特别是退伍军人。目前，没有有效的治疗方法来预防或逆转糖尿病神经病变。 一项正在进行的临床试验，改善早期糖尿病受试者的神经病变和活动性（INMED），由康复研发资助，将确定在家庭为基础的，定制的饮食和身体活动计划可以预防神经病变的进展，并改善血糖调节受损的参与者的活动性。本研究的主要终点是测量表皮内神经纤维密度（IENFD）以测量神经病变的进展，以及定时6分钟步行（6 MW）作为参与者活动性的测量。尽管INMED研究可能表明，定制的生活方式干预（饮食建议、定制的运动和活动干预）可改善或预防神经病变的进展，但尚不清楚这种获益是否持续到干预期之后，从而对受试者产生持续获益。这些信息对于确定生活方式干预的长期有效性非常重要。 本研究是IMMED应答者的随访研究，定义为与基线相比IENFD或6 MW改善的受试者。在INMED研究结束后，将对48例受试者进行额外一年的随访，不进行特定干预，以观察定制的饮食和运动计划是否会对神经病变和/或活动性的进展（由6 MW和IENFD确定）产生持续的长期获益。主要终点为额外一年结束时的6 MW，次要终点为额外一年后的IENFD和额外6个月后的6 MW。还将收集信息以确定（1）参与者是否在没有干预的情况下继续运动，（2）运动量是否在没有持续咨询的情况下减少，（3）他们是否继续保持与INMED研究中观察到的相同的改善率，以及（4）神经病变临床指标的改善是否在INMED研究之后持续。 申请人林赛齐利奥克斯博士是马里兰州大学神经病学系的助理教授，在两年内完成奖学金培训，目标是成为一名独立的VA临床研究人员。到目前为止，她的临床培训还不包括专门的研究培训时间。这2年CDA-1将允许她完成课程，通过巴尔的摩的马里兰州大学获得临床研究科学硕士学位。她还将继续由一组高级VA调查人员指导，这将提供多样化的研究经验。她的主要导师将是James Russell博士，他是一位成功的退伍军人管理局临床研究员，在糖尿病神经病变方面有着共同的研究兴趣，在过去的几年里与Zilliox博士合作，并与她共同撰写了三篇同行评议的期刊文章。此外，她将通过Neil亚历山大博士的指导，获得移动评估和运动干预领域的经验和培训。她还将获得皮肤活检的性能和解释的专业知识，用于确定表皮内神经纤维密度，这在周围神经病变研究领域是必不可少的。

DESCRIPTION Type two diabetes mellitus is a growing problem in the aging population, especially among Veterans. Currently, there is no effective therapy to prevent or reverse diabetic neuropathy. An ongoing clinical trial, Improving Neuropathy and Mobility in Subjects with Early Diabetes (INMED), funded by Rehabilitation R&D, will determine in a home based, tailored diet and physical activity program can prevent the progression of neuropathy and improve mobility in participants with impaired glucose regulation. The primary endpoints in this study are measurements of the intraepidermal nerve fiber density (IENFD) to measure the progression of neuropathy and a timed six-minute walk (6MW) as a measurement of the participants' mobility. Although the INMED study may show that a tailored lifestyle intervention (dietary advice, tailored exercise and mobility intervention) improves or prevents the progression of neuropathy, it is unknown if this benefit lasts beyond the period of the intervention and thus would have a sustained benefit to the subject. This information will be important in determining the long-term validity of the lifestyle intervention. The current study is a follow up study of the IMMED responders, defined as participants who had an improvement in the IENFD or 6MW compared to baseline. 48 subjects would be followed for an additional year without a specific intervention after the conclusion of the INMED study to see if there would be a sustained, long-term benefit of a tailored diet and exercise program on the progression of neuropathy and/or mobility as determined by the 6MW and the IENFD. The primary endpoint would be the 6MW at the conclusion of the additional year and the secondary endpoints would be the IENFD after the additional year and the 6MW after an additional 6 months. Information would also be collected to determine (1) if the participants continue to exercise without intervention, (2) if the amount o exercise decreases without ongoing counseling, (3) if they continue to maintain the same rate of improvement observed in the INMED study, and (4) if improvements in clinical measures of neuropathy are sustained beyond the INMED study. The applicant, Dr. Lindsay Zilliox, is an Assistant Professor in the Department of Neurology at the University of Maryland within two years of completing fellowship training who aims to become an independent VA clinical researcher. Her clinical training to this point has not included dedicated time for research training. This 2 year CDA-1 will allow her to complete coursework to earn a Master's of Science in Clinical Research through the University of Maryland, Baltimore. She will also continue to be mentored by a group of senior VA investigators that will provide a diverse research experience. Her primary mentor will be Dr. James Russell, who is a successful VA clinical researcher who shares a research interest in diabetic neuropathy and has worked with Dr. Zilliox over the past several years and co-authored three peer-reviewed journal articles with her. In addition she will gain experience and training in the field of mobility assessment and exercise interventions through mentorship from Dr. Neil Alexander. She will also gain expertise in the performance and interpretation of skin biopsies for the determination of intraepidermal nerve fiber density, which is essential in the field if peripheral neuropathy research.