NCT06860841Active, not recruitingPhase 4
Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM
Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and Type 2 Diabetes Mellitus: a Placebo-controlled Randomized Double-Blind Crossover Trial
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
This study evaluates the efficacy of D-Chiro-Inositol (DCI) as an add-on therapy to metformin in improving insulin resistance, measured by the HOMA index, in people with overweight or obesity and type 2 diabetes mellitus (T2DM). Secondary outcomes include glycemic variability, indirect calorimetry, respiratory quotient, and other metabolic parameters.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 21 Feb 2025
- Start date
- 10 Jan 2025
- Primary completion date
- 10 Feb 2025
- Lead sponsor
- Campus Bio-Medico University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06860841
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 16
- From 10 Jan 2025 to the primary completion date, 10 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antidiabetic drugs other than metformin within three months prior to enrollment.
- History of ketoacidosis or severe hypoglycemia within six months prior to enrollment.
Lab values
- Significant renal or hepatic impairment (eGFR \<60 mL/min/1.73 m²; ALT/AST \>2× ULN).
Other
- Pregnancy or lactation.
Who the study is looking for
- Diagnosis of type 2 diabetes mellitus.
- Age between 18-75 years.
- BMI ≥25 kg/m².
- HbA1c \< 9%.
- Stable dose of metformin for at least three months prior to enrollment.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.