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D-chiro-Inositol in Overweight Type 1 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT02730949
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Professor Paolo Pozzilli, Campus Bio-Medico University

Study Description
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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


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Dietary Supplement: D-chiro-inositol Dietary Supplement: Folic Acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 g D-chiro-Inositol + 400 mcg Folic Acid
1 g D-chiro-Inositol + 400 mcg folic acid once daily
 Dietary Supplement: D-chiro-inositol
Treated group

Dietary Supplement: Folic Acid
Control group
Active Comparator: 400 mcg folic
400 mcg folic acid only once daily
 Dietary Supplement: Folic Acid
Control group


Outcome Measures
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Primary Outcome Measures :
  1. efficacy of DCI oral supplementation on metabolic control [ Time Frame: 6 months ]
    efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)


Secondary Outcome Measures :
  1. BMI kg/m2 [ Time Frame: 6 months ]
    reduction of BMI

  2. Insulin Requirement (I.R.) IU/kg [ Time Frame: 6 months ]
    reduction of I.R.


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730949


Locations
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Italy
University Campus Bio Medico
Rome, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
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Principal Investigator: Paolo Pozzilli, MD University Campus Bio-medico
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Paolo Pozzilli, Prof, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT02730949    
Other Study ID Numbers: 16/14PARComETCBM
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Professor Paolo Pozzilli, Campus Bio-Medico University:
D-Chiro-Inositol, type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Body Weight
Folic Acid
Inositol
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs