D-chiro-Inositol in Overweight Type 1 Diabetes Patients

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Dietary Supplement: Folic Acid; Dietary Supplement: D-chiro-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT02730949

16/14PARComETCBM

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

1 g D-chiro-Inositol + 400 mcg Folic Acid

Experimental group

Description:

1 g D-chiro-Inositol + 400 mcg folic acid once daily

Treatment:

Dietary Supplement: D-chiro-inositol

Dietary Supplement: Folic Acid

400 mcg folic

Active Comparator group

Description:

400 mcg folic acid only once daily

Treatment:

Dietary Supplement: Folic Acid