Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— ACUDIA  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04076800
• Other study ID #: 13181
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Antonio Silverii, MD
• Phone: +393335441169
• Email: antonio.silverii[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: October 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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).

Locations

Country	Name	City	State
Italy	Diabetologia AOU Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin daily doses	Doses of insulin after standardized titration	12 weeks
Secondary	HbA1c	Variations of HbA1c from beginning to end of each treatment phase	12 weeks