Type 1 DiabetesPhase 3NCT02730949
D-chiro-Inositol in Overweight Type 1 Diabetes Patients
A Phase 3 study testing D-chiro-inositol and Folic Acid in people with Type 1 Diabetes, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- D-chiro-inositol and Folic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- T1D patients
- aged 17-50 years
- disease duration > 1 year
- BMI >25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
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
- Conditions
- Type 1 Diabetes
- Being tested
- D-chiro-inositol, Folic Acid
- Keywords
- D-Chiro-Inositol, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiro-inositolDietary supplement
Treated group
Folic AcidDietary supplement
Control group
| Study group | Role | What they receive |
|---|---|---|
| 1 g D-chiro-Inositol + 400 mcg Folic Acid | Experimental | 1 g D-chiro-Inositol + 400 mcg folic acid once daily Receives: Dietary Supplement: D-chiro-inositol; Dietary Supplement: Folic Acid |
| 400 mcg folic | Active comparator | 400 mcg folic acid only once daily Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of DCI oral supplementation on metabolic control
efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)
Measured: 6 months
Secondary outcomes (2)
BMI kg/m2
reduction of BMI
Measured: 6 months
Insulin Requirement (I.R.) IU/kg
reduction of I.R.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Paolo Pozzilli, Campus Bio-Medico University
- Investigators
- Paolo Pozzilli, MD, Principal investigator, University Campus Bio-medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730949
- Sponsor's protocol ID
- 16/14PARComETCBM
- Status last verified
- Apr 2016
- First submitted
- 25 Mar 2016
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28039583
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02730949
- Acronym / sponsor ID
- 16/14PARComETCBM
- Conditions
- Type 1 Diabetes
- Keywords
- D-Chiro-Inositol, type 1 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 g D-chiro-Inositol + 400 mcg Folic Acid | Experimental | Dietary Supplement: D-chiro-inositol, Dietary Supplement: Folic Acid1 g D-chiro-Inositol + 400 mcg folic acid once daily |
| 400 mcg folic | Active comparator | Dietary Supplement: Folic Acid400 mcg folic acid only once daily |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- T1D patients
- aged 17-50 years
- disease duration > 1 year
- BMI >25
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-chiro-inositolTreated group | Dietary supplement | 1 g D-chiro-Inositol + 400 mcg Folic Acid |
| Folic AcidControl group | Dietary supplement | 1 g D-chiro-Inositol + 400 mcg Folic Acid, 400 mcg folic |
Primary outcome
efficacy of DCI oral supplementation on metabolic control
Time frame: 6 months
efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)
2 secondary outcomes
BMI kg/m2
Time frame: 6 months
Insulin Requirement (I.R.) IU/kg
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Derived from this study: PubMed 28039583Maurizi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pozzilli, MD principal investigator
University Campus Bio-medico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D-chiro-inositol and Folic Acid in people with Type 1 Diabetes, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of DCI oral supplementation on metabolic control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.