Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04076800

Acronym

ACUDIA

Enrollment

Registered

2019-09-03

Start date

2019-08-01

Completion date

2023-10-31

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

acupuncture, insulin sensitivity

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).

Interventions

PROCEDUREAcupuncture

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).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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)

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactAntonio Silverii, MD

antonio.silverii@gmail.com+393335441169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026