D-chiro-Inositol in Overweight Type 1 Diabetes Patients

Phase 3

Completed

• Conditions: Type 1 Diabetes
• Interventions: Dietary Supplement: D-chiro-inositol; Dietary Supplement: Folic Acid

• Registration Number: NCT02730949
• Lead Sponsor: Campus Bio-Medico University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-05
• Study Completion: 2015-12
• Study First Submitted: 2016-03-25
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-01
• Last Update Submitted: 2016-04-01
• Study First Posted: 2016-04-07
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 g D-chiro-Inositol + 400 mcg Folic Acid	D-chiro-inositol	1 g D-chiro-Inositol + 400 mcg folic acid once daily
1 g D-chiro-Inositol + 400 mcg Folic Acid	Folic Acid	1 g D-chiro-Inositol + 400 mcg folic acid once daily
400 mcg folic	Folic Acid	400 mcg folic acid only once daily

Primary Outcome Measures

Name	Time	Method
efficacy of DCI oral supplementation on metabolic control	6 months	efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)

Secondary Outcome Measures

Name	Time	Method
BMI kg/m2	6 months	reduction of BMI
Insulin Requirement (I.R.) IU/kg	6 months	reduction of I.R.

Trial Locations

Locations (1)

University Campus Bio Medico; 🇮🇹 Rome, Italy