title: A pilot study of D-chiro-inositol plus folic acid in overweight patients with type 1 diabetes.
abstract: To improve insulin sensitivity, insulin-sensitizing drugs such as metformin are commonly used in overweight and obese T1D patients. Similarly to metformin, D-chiro-inositol (DCI), as putative mediator of intracellular insulin action, can act as insulin sensitizer. The aim of this pilot study was to evaluate the hypothesis that DCI plus folic acid may improve glucose control reducing insulin resistance in overweight or obese T1D patients.
  
  
  
  A 24-week randomized control trial was carried out in 26 overweight or obese T1D patients, undergoing intensive insulin therapy. Patients were randomized to 1 g DCI plus 400 mcg folic acid once daily (treated group) or to 400 mcg folic acid only once daily (control group). The primary end point was to evaluate the efficacy of DCI on metabolic control as assessed by HbA1c. As secondary endpoints, BMI and insulin requirement (IR) were evaluated. Paired t test (two tailed) and analysis of variance were used to evaluate differences in HbA1c, BMI and IR at different time points.
  
  
  
  A significant reduction in HbA1c levels in treated group versus control group (7.5% ± 0.9 vs. 7.9% ± 1.7, respectively, p < 0.05) was observed. However, no significant reduction in BMI and IR was observed [(BMI 25.7 ± 2.8 vs. 26.7 ± 1.0, respectively, p NS); (IR 0.52 ± 0.26 vs. 0.52 ± 0.19, respectively, p NS)].
  
  
  
  This trial demonstrated for the first time that DCI plus folic acid oral supplementation can improve metabolic control in overweight T1D patients. CLINICALTRIAL.
  
  
  
  NCT02730949.
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy. a.maurizi@unicampus.it.
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Maurizi
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Marika
authors.initials: M
authors.lastname: Menduni
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Del Toro
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Shadi
authors.initials: S
authors.lastname: Kyanvash
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Daria
authors.initials: D
authors.lastname: Maggi
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Guglielmi
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Angelo Lauria
authors.initials: AL
authors.lastname: Pantano
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Defeudis
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Elvira
authors.initials: E
authors.lastname: Fioriti
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Manfrini
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy.|Centre of Diabetes, Bart's and The London School of Medicine and Dentistry, Queen Mary's University of London, London, UK.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pozzilli
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage*; D006801:Humans; D007294:Inositol / Q000008:administration & dosage*; D007328:Insulin / Q000378:metabolism; D007333:Insulin Resistance; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D050177:Overweight / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D010865:Pilot Projects; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007328:Insulin; D007294:Inositol; D008687:Metformin; D005492:Folic Acid
keywords: D-chiro-Inositol (DCI); Folic acid; Glycaemic control; Insulin resistance; Insulin therapy; Type 1 diabetes