D-chiro-Inositol in Overweight Type 1 Diabetes Patients

Campus Bio-Medico University26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

D-chiro-inositolDIETARY_SUPPLEMENT

Treated group

Folic AcidDIETARY_SUPPLEMENT

Control group

Eligibility

Sex: ALLMin age: 17 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University Campus Bio Medico

Rome, Italy

Outcomes

Primary Outcomes

efficacy of DCI oral supplementation on metabolic control

efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)

Time frame: 6 months

Secondary Outcomes

BMI kg/m2

reduction of BMI

Time frame: 6 months

Insulin Requirement (I.R.) IU/kg

reduction of I.R.

Time frame: 6 months

Data from ClinicalTrials.gov

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