D-chiro-Inositol in Overweight Type 1 Diabetes Patients
A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
1 other identifier
interventional
26
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedApril 7, 2016
April 1, 2016
1.2 years
March 25, 2016
April 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy of DCI oral supplementation on metabolic control
efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)
6 months
Secondary Outcomes (2)
BMI kg/m2
6 months
Insulin Requirement (I.R.) IU/kg
6 months
Study Arms (2)
1 g D-chiro-Inositol + 400 mcg Folic Acid
EXPERIMENTAL1 g D-chiro-Inositol + 400 mcg folic acid once daily
400 mcg folic
ACTIVE COMPARATOR400 mcg folic acid only once daily
Interventions
Eligibility Criteria
You may qualify if:
- T1D patients
- aged 17-50 years
- disease duration \> 1 year
- BMI \>25
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Campus Bio Medico
Rome, 00128, Italy
Related Publications (1)
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.
PMID: 28039583DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Pozzilli, MD
University Campus Bio-medico
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 7, 2016
Study Start
March 1, 2014
Primary Completion
May 1, 2015
Study Completion
December 1, 2015
Last Updated
April 7, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share