D-chiro-Inositol in Overweight Type 1 Diabetes Patients
NCT ID: NCT02730949
Last Updated: 2016-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2014-03-31
2015-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 g D-chiro-Inositol + 400 mcg Folic Acid
1 g D-chiro-Inositol + 400 mcg folic acid once daily
D-chiro-inositol
Treated group
Folic Acid
Control group
400 mcg folic
400 mcg folic acid only once daily
Folic Acid
Control group
Interventions
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D-chiro-inositol
Treated group
Folic Acid
Control group
Eligibility Criteria
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Inclusion Criteria
* aged 17-50 years
* disease duration \> 1 year
* BMI \>25
Exclusion Criteria
* 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
17 Years
50 Years
ALL
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Professor Paolo Pozzilli
Prof
Principal Investigators
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Paolo Pozzilli, MD
Role: PRINCIPAL_INVESTIGATOR
University Campus Bio-medico
Locations
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University Campus Bio Medico
Rome, , Italy
Countries
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References
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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.
Other Identifiers
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16/14PARComETCBM
Identifier Type: -
Identifier Source: org_study_id
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