NCT01565317已完成不适用
Evaluation of the Effect of Intensive Diabetes Control Through Non-Surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Sural nerve conduction velocity
研究概览
简要总结
The purpose of this study is to find out the impact of improving diabetes control through weight reduction and lifestyle changes on a common diabetes complication called peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion of Intervention group:
- •Men and Women with established Diabetes.
- •BMI between 30-45 Kg/m2
- •Age: 18-75 years old.
- •Enrolled in the Why WAIT program
- •Diabetes duration of at least 5 years
- •Hb A1C of 6.5% or higher
- •Inclusion of controls:
- •Men and Women with established Diabetes.
- •BMI between 30-45 Kg/m2
- •Age: 18-75 years old.
- •Diabetes duration of at least 5 years
- •Hb A1C of 6.5% or higher
排除标准
- •Anatomic changes that preclude the measurement of the nerve conduction: foot deformities, open skin injuries/ulcers, amputations and placement of surgical plates and screws in the ankle and lower leg (tibial) area.
- •Severe diabetic peripheral neuropathy as defined clinically.
- •Severe peripheral vascular disease e.g absent dorsalis pedis pulsation.
- •Recent weight loss/gain (10 pounds) during the past six months.
- •Neuropathy due to other causes other than diabetes: Alcohol abuse, Liver/Renal disease, Toxic exposure, Inflammatory Disease, Nutritional and Vitamin deficiencies.
- •Individuals with cardiac pacemakers.
- •Women who are Pregnant or who think they might be pregnant.
结局指标
主要结局
Change in Sural nerve conduction velocity
时间窗: Baseline, at 3 months, at 6 months, at 12 months
The NCstat DPNCheck device(an FDA approved device) measures the sural nerve conduction velocity. The sural nerve conduction velocity is the gold standard in assessing diabetic peripheral neuropathy.
次要结局
- Change in Sural Nerve Amplitude potential(Baseline, at 3 months, at 6 months, at 12 months)
研究者
Osama Hamdy
Principal Investigator
Joslin Diabetes Center
研究点 (2)
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