Evaluation of the Effect of Intensive Diabetes Control Through Non-Surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 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.
研究组 & 干预措施
Intensive Treatment (Why WAIT)
Weight Achievement and Intensive Treatment (Why WAIT) is a 12 -week multidisciplinary program for weight control and intensive diabetes management designed by the Joslin Diabetes Center for application in a multidisciplinary diabetes practice environment. Participants will be enrolled in a 12-week multidisciplinary intensive weight management including diet, exercise, behavioral and educational support. Participants will be enrolled in cohorts of 10-15 participants to encourage group interaction and support. Subjects will choose to come to the Joslin clinic every Tuesday or Wednesday evening for 2 hours. Participants will exercise for an hour and will attend a didactic session in the areas of nutrition, exercise and behavioral modifications.
干预措施: Weight Achievement and Intensive Treatment (Why WAIT) (Other)
Control Group
Matched control group will be recruited from obese patients with diabetes followed at Joslin Clinic. This group will receive the routine standard diabetes care.
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