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

A

Azienda Ospedaliero-Universitaria Careggi

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

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

42 participants in 2 patient groups

Acupuncture
Experimental group
Treatment:
Procedure: Acupuncture
Sham acupuncture
Sham Comparator group
Treatment:
Procedure: Acupuncture

Trial contacts and locations

1

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Central trial contact

Antonio Silverii, MD

Data sourced from clinicaltrials.gov

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