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临床试验/NCT04076800
NCT04076800Unknown不适用

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.

Azienda Ospedaliero-Universitaria Careggi2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edoardo Mannucci

Director, Diabetology

Azienda Ospedaliero-Universitaria Careggi

研究点 (2)

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