Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM (DIACHIRO)

March 6, 2025 updated by: Silvia Manfrini, Campus Bio-Medico University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The DIACHIRO trial is a randomized, double-blind, crossover clinical trial assessing the impact of DCI combined with metformin versus metformin plus placebo on insulin resistance in people with overweight or obesity and T2DM. The primary outcome is the change in the HOMA index. Secondary outcomes include glycemic variability parameters (e.g., time in range), oxidative stress markers, indirect calorimetry, respiratory quotient, and HbA1c levels. Participants are monitored using Flash Glucose Monitoring (FGM) systems.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of type 2 diabetes mellitus.
  2. Age between 18-75 years.
  3. BMI ≥25 kg/m².
  4. HbA1c < 9%.
  5. Stable dose of metformin for at least three months prior to enrollment.

Exclusion Criteria:

  1. Use of antidiabetic drugs other than metformin within three months prior to enrollment.
  2. History of ketoacidosis or severe hypoglycemia within six months prior to enrollment.
  3. Significant renal or hepatic impairment (eGFR <60 mL/min/1.73 m²; ALT/AST >2× ULN).
  4. Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Intervention/Treatment
D-Chiro-Inositol in combination with metformin
Drug: D-Chiro-Inositol Combined with Metformin
D-chiro-Inositol will be administered for 14 days,1 cp after lunch and 1 cp after dinner in addition to preexisting metformin therapy
Active Comparator: Active Comparator Intervention/Treatment
Placebo in combination with metformin
Drug: Placebo in combination with metformin
placebo will be administerd for 14 days, 1 cp after lunch and 1 cp after dinner in addition to pre-existing metformin therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the HOMA index
Time Frame: at the end of treatment phase (two weeks)
fasting glucose and insulin will be measured
at the end of treatment phase (two weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range in %
Time Frame: at the end of treatment (two weeks)
Time in range in % (time spent with a glucose level between 70-180 mg/dL expressed in %)
at the end of treatment (two weeks)
Changes in oxidative stress markers
Time Frame: at the end of treatment (two weeks)
D-ROM PAT
at the end of treatment (two weeks)
Indirect calorimetry measurements
Time Frame: at the end of treatment (two weeks)
Indirect calorimetry measurements
at the end of treatment (two weeks)
Respiratory quotient measurements.
Time Frame: at the end of treatment (two weeks)
Respiratory quotient measurements.
at the end of treatment (two weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Actual)

February 10, 2025

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The DIACHIRO Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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