Comparison of the Effects of a Standardized Acupuncture Treatment and Sham Acupuncture on Insulin Doses in Insulin-treated Patients With Type 2 Diabetes. A Randomized, Single-blind, Crossover Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Insulin daily doses
研究概览
简要总结
This study is a randomized, single blinded, cross-over interventional study for evaluating the effect of acupuncture versus sham acupuncture in diabetic type 2 patient in insulin treatment. Primary end-point of the study is the difference of daily units of insulin between treatment and control group; secondary end point are the variation of glycated hemoglobin levels, lipids panel (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides), C reactive protein and adiponectin. Variation of epicardial fat thickness will be also evaluated by echography. Acupuncture and sham treatment will be administered twice a week for 3 months and, after a pause of one month and cross-over between groups for other three months. Acupuncture treatment will include use of somatic points (SP6; ST36; KI3; CV4; CV12; TE5; LI4; LI11; YinTang; ST28; BL23; BL22; BL20; BL13) and auricular points (most tender point on palpation with pressure feelers of 400 g on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points). Sham acupuncture will be applied distal from acupuncture points and areas used for treatment, with shallow insertion and without manipulation of the needle (15 needles in total on thorax, abdomen, back, arms and legs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 Diabetes Mellitus
- •insulin therapy > 20 UI daily for at least 6 months
- •HbA1c < 69 mmol/mol
排除标准
- •Class I Psychiatric illness not adequately treated
- •Actual pregnancy or breastfeeding, or pregnancy planning.
- •Corticosteroid treatment
- •Severe heart failure (NYHA III-IV)
- •Severe renal failure (pre-dialysis o dialysis),
- •Severe liver insufficiency (overt cirrhosis)
- •Severe respiratory failure (oxygen therapy)
结局指标
主要结局
Insulin daily doses
时间窗: 12 weeks
Doses of insulin after standardized titration
次要结局
- HbA1c(12 weeks)
研究者
Edoardo Mannucci
Director, Diabetology
Azienda Ospedaliero-Universitaria Careggi
