D-chiro-Inositol in Overweight Type 1 Diabetes Patients

Type 1 Diabetes Clinical Trial

Official title:

A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730949
• Other study ID #: 16/14PARComETCBM
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2016
• Last updated: April 1, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Dietary Supplement:
• D-chiro-inositol
Treated group
• Folic Acid
Control group

Locations

Country	Name	City	State
Italy	University Campus Bio Medico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of DCI oral supplementation on metabolic control	efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)	6 months	Yes
Secondary	BMI kg/m2	reduction of BMI	6 months	Yes
Secondary	Insulin Requirement (I.R.) IU/kg	reduction of I.R.	6 months	Yes