D-chiro-Inositol in Overweight Type 1 Diabetes Patients
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
D-chiro-inositol
Folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring D-Chiro-Inositol, type 1 diabetes
Eligibility Criteria
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
Sites / Locations
- University Campus Bio Medico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 g D-chiro-Inositol + 400 mcg Folic Acid
400 mcg folic
Arm Description
1 g D-chiro-Inositol + 400 mcg folic acid once daily
400 mcg folic acid only once daily
Outcomes
Primary Outcome Measures
efficacy of DCI oral supplementation on metabolic control
efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)
Secondary Outcome Measures
BMI kg/m2
reduction of BMI
Insulin Requirement (I.R.) IU/kg
reduction of I.R.
Full Information
NCT ID
NCT02730949
First Posted
March 25, 2016
Last Updated
April 1, 2016
Sponsor
Campus Bio-Medico University
1. Study Identification
Unique Protocol Identification Number
NCT02730949
Brief Title
D-chiro-Inositol in Overweight Type 1 Diabetes Patients
Official Title
A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
D-Chiro-Inositol, type 1 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 g D-chiro-Inositol + 400 mcg Folic Acid
Arm Type
Experimental
Arm Description
1 g D-chiro-Inositol + 400 mcg folic acid once daily
Arm Title
400 mcg folic
Arm Type
Active Comparator
Arm Description
400 mcg folic acid only once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
D-chiro-inositol
Intervention Description
Treated group
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid
Intervention Description
Control group
Primary Outcome Measure Information:
Title
efficacy of DCI oral supplementation on metabolic control
Description
efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
BMI kg/m2
Description
reduction of BMI
Time Frame
6 months
Title
Insulin Requirement (I.R.) IU/kg
Description
reduction of I.R.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pozzilli, MD
Organizational Affiliation
University Campus Bio-medico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Campus Bio Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28039583
Citation
Maurizi AR, Menduni M, Del Toro R, Kyanvash S, Maggi D, Guglielmi C, Pantano AL, Defeudis G, Fioriti E, Manfrini S, Pozzilli P. A pilot study of D-chiro-inositol plus folic acid in overweight patients with type 1 diabetes. Acta Diabetol. 2017 Apr;54(4):361-365. doi: 10.1007/s00592-016-0954-x. Epub 2016 Dec 30.
Results Reference
derived
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D-chiro-Inositol in Overweight Type 1 Diabetes Patients
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