Activity for Diabetic Polyneuropathy: the ADAPT Study
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Change in Intraepidermal Nerve Fiber Density (IENFD)
研究概览
简要总结
The proposed study will randomize participants with diabetic peripheral neuropathy into two groups. One group of participants will receive standard-of-care counseling while the other group will undergo supervised exercise and counseling to increase physical activity.
详细描述
Type 2 diabetes (T2D) affects over 8% of Americans, and half will develop peripheral neuropathy, a progressive injury to the very longest nerves of the body. Our previous research has found that neuropathy can be detected early in its course and followed by examining nerves that reach to the skin using a small punch biopsy. These cutaneous nerves can be injured by high blood glucose, obesity and high triglycerides, but have the potential to regrow in response to treatments that improve these metabolic conditions. The proposed study will randomize participants with mild to moderate diabetic peripheral neuropathy to receive either generic annual counseling or an integrated program of moderate supervised exercise and actigraphy based anti sedentariness counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2D defined by ADA criteria.
- •Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus criteria for "Confirmed diabetic sensorimotor peripheral neuropathy".
- •Moderate DPN severity with a UENS of 2-
- •Age between 30 and
- •Under the care of an identified Primary Care Physician (PCP).
排除标准
- •Any alternative cause for peripheral neuropathy. The following tests must have been found normal within the last 12 months or will be performed pre-randomization: vitamin B12, serum protein electrophoresis and immunofixation. ANA and TSH may be obtained if clinically indicated and not available from clinical records.
- •Family history of a non-diabetic neuropathy in a first-degree relative.
- •Severe or longstanding neuropathy: UENS > 18 or history of foot ulceration or amputation.
- •Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be considered on an individual basis by the site investigator.
- •Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
- •A serious medical condition that might shorten life span or prevent exercise.
- •Subjects with obesity or hypertension considered in a dangerous range (BMI> 45, systolic BP >170, or diastolic BP >110) and those who fail a medically supervised graded maximal stress test will be excluded from the study for safety reasons.
- •An inability to understand or cooperate with the procedures of the study
- •Females who are pregnant at screening or actively plan to become pregnant during the study period, because of the marked changes in metabolism anticipated during pregnancy.
- •If ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition.
结局指标
主要结局
Change in Intraepidermal Nerve Fiber Density (IENFD)
时间窗: Baseline, 9 months, and 18 months
Change in Quality of Life (NQOL-DN) Questionnaire Results
时间窗: Baseline, 9 months, and 18 months
次要结局
未报告次要终点