Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Procedure: Acupuncture

• Registration Number: NCT04076800
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham acupuncture	Acupuncture	-
Acupuncture	Acupuncture	-

Primary Outcome Measures

Name	Time	Method
Insulin daily doses	12 weeks	Doses of insulin after standardized titration

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	Variations of HbA1c from beginning to end of each treatment phase

Trial Locations

Locations (1)

Diabetologia AOU Careggi; 🇮🇹 Firenze, Italy