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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Procedure: Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Silverii, MD; Phone Number: +393335441169; Email: antonio.silverii@gmail.com

Study Locations

• Italy
  • Firenze, Italy, 50134
    • Recruiting
    • Diabetologia AOU Careggi
    • Contact: Ilaria Dicembrini, MD; Phone Number: 0557946512; Email: idicembrini@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture	Procedure: Acupuncture; 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 gr on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points).
Sham Comparator: Sham acupuncture	Procedure: Acupuncture; 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 gr on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin daily doses	Doses of insulin after standardized titration	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Variations of HbA1c from beginning to end of each treatment phase	12 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: insulin sensitivity; acupuncture
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 13181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No