D-chiro-Inositol in Overweight Type 1 Diabetes Patients

Last updated: April 1, 2016
Sponsor: Campus Bio-Medico University
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Obesity

Treatment

N/A

Clinical Study ID

NCT02730949
16/14PARComETCBM
  • Ages 17-50
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • T1D patients

  • aged 17-50 years

  • disease duration > 1 year

  • BMI >25

Exclusion

Exclusion Criteria:

  • learning disabilities

  • presence of chronic conditions potentially able to influence daily activities (visualor auditory disability, motor impairment for neurological or orthopaedic problems).

  • T1D patients affected from diabetic complications

  • pregnancy

Study Design

Total Participants: 26
Study Start date:
March 01, 2014
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • University Campus Bio Medico

    Rome, 00128
    Italy

    Site Not Available

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