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D-chiro-Inositol in Overweight Type 1 Diabetes Patients

NCT02730949 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-04-07

No results posted yet for this 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

Conditions

Interventions

DIETARY_SUPPLEMENT

D-chiro-inositol

Treated group

DIETARY_SUPPLEMENT

Folic Acid

Control group

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Paolo Pozzilli, MD · University Campus Bio-medico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730949 on ClinicalTrials.gov