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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring acupuncture, insulin sensitivity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Diabetologia AOU CareggiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Insulin daily doses
Doses of insulin after standardized titration

Secondary Outcome Measures

HbA1c
Variations of HbA1c from beginning to end of each treatment phase

Full Information

First Posted
August 30, 2019
Last Updated
July 19, 2022
Sponsor
Azienda Ospedaliero-Universitaria Careggi
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1. Study Identification

Unique Protocol Identification Number
NCT04076800
Brief Title
Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
acupuncture, insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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).
Primary Outcome Measure Information:
Title
Insulin daily doses
Description
Doses of insulin after standardized titration
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
Variations of HbA1c from beginning to end of each treatment phase
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Silverii, MD
Phone
+393335441169
Email
antonio.silverii@gmail.com
Facility Information:
Facility Name
Diabetologia AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Dicembrini, MD
Phone
0557946512
Email
idicembrini@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes

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