The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Level of improvement of gastric emptying rate
研究概览
简要总结
Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach.Treatment with acupuncture has been described as effective in improvement of symptoms in patients with gastroparesis in a number of patient series. However, this treatment approach has not been tested by means of a controlled randomized clinical study, and neither has the connection between improvement of symptoms and the anatomical-physiological effect of the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice daily) as compared to acupuncture treatment on the following subjective and objective parameters of 30 patients with diabetic gastroparesis and impaired glucose control:
- To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire.
- To determine the effect of treatment with motilium or acupuncture on gastric emptying rate.
- To determine the effect of treatment with motilium or acupuncture on glycemic control.
- To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).
详细描述
This is a randomized, comparative, pilot study, which will compare two treatments: acupuncture treatment vs. treatment with motilium in 30 diabetic patients with impaired glucose control and gastroparesis.
All patients who meet inclusion criteria will undergo gastric scintigraphy and upper endoscopy to assess the presence of gastroparesis and to rule out gastric outlet obstruction. At baseline, all enrolled patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI), the Quality of life questionnaire (SF-36). Subsequently, patients will be randomized to 20 mg motilium thrice daily and after 1 month wash-out period to acupuncture treatment, each treatment will last 12 weeks.
After treatment, patients will undergo a second gastric scintigraphy and will complete the GCSI and the SF-36.
Fasting blood glucose concentrations and HbA1c levels will be determined at the beginning and at the end of the study and at 6 months later as well.
End Points:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80,
- •Diabetic patients of over 10 years duration with impaired glucose control, after at least 6 months of accepted treatment in a Diabetes Clinic by the study staff before inclusion in the study, who exhibit symptoms which could signify the possibility of diabetic gastroparesis.
排除标准
- •Known hyperprolactinemia, systemic or localized neurological disturbances (myopathy, multiple sclerosis, Parkinson's disease, myelopathy), with the exception of diabetic neuropathy, past stomach or esophagus surgery, pregnancy, inability to sign Informed Consent, fear of acupuncture, limb amputation.
研究组 & 干预措施
Motillium
20 mg motilium thrice daily for 12 weeks.
干预措施: Motilium (Drug)
Acupuncture
Acupuncture treatment.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Level of improvement of gastric emptying rate
时间窗: 6 months
次要结局
- Improvement in blood glucose levels(6 months)