Insulin ResistanceNCT05348941
Efficacy and Safety of D-chiro-inositol in Obese Patients
A study testing TECADRIOL in people with Insulin Resistance, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- TECADRIOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2022to 1 Nov 2023
- Phase
- Interventional
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 25 and 40 years old
- Diagnosis of insulin resistance (HOMA ≥2.5)
- 26≤ BMI ≤32
Who cannot join
- Subjects with no indication for treatment
- Pregnancy and breastfeeding
- Treatment with drugs or supplements that interfere with the mechanism of action of insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients
The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet
Read the detailed description
Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.
However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.
It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.
Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.
- Conditions
- Insulin Resistance
- Being tested
- TECADRIOL
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECADRIOLDietary supplement
Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Hypocaloric balanced diet |
| TECADRIOL | Experimental | Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin Receives: Dietary Supplement: TECADRIOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA index
Reduction of HOMA index
Measured: Three time points: change in HOMA index from the baseline to 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Jun 2022
- Primary completion27 Sep 2022
- Study completion1 Nov 2023
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 Insulin ResistanceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348941
- Sponsor's protocol ID
- DCI_DIET22
- Status last verified
- May 2025
- First submitted
- 22 Apr 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basciani S, Nordio M, Spizzichini ML, Gnessi L. Unexpected effects of treating insulin-resistant obese women with high-dose D-chiro-inositol: opening Pandora's box. Front Endocrinol (Lausanne). 2025 Apr 1;16:1399308. doi: 10.3389/fendo.2025.1399308. eCollection 2025.
PubMed 40235665
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients
- ClinicalTrials.gov ID
- NCT05348941
- Acronym / sponsor ID
- DCI_DIET22
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- 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 study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet
Detailed description
Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.
However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.
It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.
Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Hypocaloric balanced diet |
| TECADRIOL | Experimental | Dietary Supplement: TECADRIOLHypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between 25 and 40 years old
- Diagnosis of insulin resistance (HOMA ≥2.5)
- 26≤ BMI ≤32
Key exclusion criteria (3 listed)
- Subjects with no indication for treatment
- Pregnancy and breastfeeding
- Treatment with drugs or supplements that interfere with the mechanism of action of insulin
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 |
|---|---|---|
| TECADRIOLFood supplement containing an association of D-chiro-inositol and alpha-lactalbumin | Dietary supplement | TECADRIOL |
Primary outcome
HOMA index
Time frame: Three time points: change in HOMA index from the baseline to 2 and 4 months
Reduction of HOMA index
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 4 Jun 2025.
- Derived from this study: PubMed 40235665Basciani S, Nordio M, Spizzichini ML, Gnessi L. Unexpected effects of treating insulin-resistant obese women with high-dose D-chiro-inositol: opening Pandora's box. Front Endocrinol (Lausanne). 2025 Apr 1;16:1399308. doi: 10.3389/fendo.2025.1399308. eCollection 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECADRIOL in people with Insulin Resistance, run by Lo.Li.Pharma s.r.l 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 3 inclusion and 3 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 4 Jun 2025. 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.
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?
HOMA index (time frame: Three time points: change in HOMA index from the baseline to 2 and 4 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 NCT05348941, 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 4 Jun 2025.