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Completed

NCT Number: NCT02730949

D-chiro-Inositol in Overweight Type 1 Diabetes Patients

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Campus Bio Medico

Rome, 00128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-chiro-inositol

Dietary Supplement

Treated group

Folic Acid

Dietary Supplement

Control group

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2016
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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