Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes (ACUDIA)

Azienda Ospedaliero-Universitaria Careggi

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04076800

13181

Details and patient eligibility

About

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).

Enrollment: 42 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 Diabetes Mellitus
• insulin therapy > 20 UI daily for at least 6 months
• HbA1c < 69 mmol/mol

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Acupuncture

Experimental group

Treatment:

Procedure: Acupuncture

Sham acupuncture

Sham Comparator group

Treatment:

Procedure: Acupuncture