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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental |
| |
| Sham acupuncture | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin daily doses | Doses of insulin after standardized titration | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Variations of HbA1c from beginning to end of each treatment phase | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Silverii, MD | Contact | +393335441169 | antonio.silverii@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetologia AOU Careggi | Recruiting | Florence | 50134 | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 13, 2026 | |
| Reset | Mar 31, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 13, 2026 | Mar 31, 2026 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |