NCT04076800

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4.2 years

First QC Date

August 30, 2019

Last Update Submit

July 19, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

acupunctureinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Insulin daily doses

    Doses of insulin after standardized titration

    12 weeks

Secondary Outcomes (1)

  • HbA1c

    12 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL
Procedure: Acupuncture

Sham acupuncture

SHAM COMPARATOR
Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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).

AcupunctureSham acupuncture

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 Diabetes Mellitus
  • insulin therapy \> 20 UI daily for at least 6 months
  • HbA1c \< 69 mmol/mol

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetologia AOU Careggi

Florence, 50134, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Antonio Silverii, MD

CONTACT

+393335441169antonio.silverii@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Diabetology

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 3, 2019

Study Start

August 1, 2019

Primary Completion

September 30, 2023

Study Completion

October 31, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)