Type 1 Diabetes
Conditions
Keywords
D-Chiro-Inositol, type 1 diabetes
Brief summary
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
Interventions
DIETARY_SUPPLEMENTD-chiro-inositol
Treated group
DIETARY_SUPPLEMENTFolic Acid
Control group
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* T1D patients * aged 17-50 years * disease duration \> 1 year * BMI \>25
Exclusion criteria
* learning disabilities * presence of chronic conditions potentially able to influence daily activities (visual or auditory disability, motor impairment for neurological or orthopaedic problems). * T1D patients affected from diabetic complications * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of DCI oral supplementation on metabolic control | 6 months | efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI kg/m2 | 6 months | reduction of BMI |
| Insulin Requirement (I.R.) IU/kg | 6 months | reduction of I.R. |
Countries
Italy
Outcome results
None listed