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The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral supplementation in addiction to folic acid compared to folic acid alone on glycaemic control as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin therapy.
A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50 years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 g D-chiro-Inositol + 400 mcg Folic Acid | Experimental | 1 g D-chiro-Inositol + 400 mcg folic acid once daily |
|
| 400 mcg folic | Active Comparator | 400 mcg folic acid only once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-chiro-inositol | Dietary Supplement | Treated group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of DCI oral supplementation on metabolic control | efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI kg/m2 | reduction of BMI | 6 months |
| Insulin Requirement (I.R.) IU/kg | reduction of I.R. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Pozzilli, MD | University Campus Bio-medico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Campus Bio Medico | Rome | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28039583 | Derived | Maurizi AR, Menduni M, Del Toro R, Kyanvash S, Maggi D, Guglielmi C, Pantano AL, Defeudis G, Fioriti E, Manfrini S, Pozzilli P. A pilot study of D-chiro-inositol plus folic acid in overweight patients with type 1 diabetes. Acta Diabetol. 2017 Apr;54(4):361-365. doi: 10.1007/s00592-016-0954-x. Epub 2016 Dec 30. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Folic Acid |
| Dietary Supplement |
Control group |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006571 | Heterocyclic Compounds |