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

NCT ID: NCT06860841

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-04-10

Brief Summary

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.

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.

Conditions

Type 2 Diabetes; Overweight and Obese Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Intervention/Treatment

D-Chiro-Inositol in combination with metformin

Group Type: EXPERIMENTAL

D-Chiro-Inositol Combined with Metformin

Intervention Type: DRUG

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 Intervention/Treatment

Placebo in combination with metformin

Group Type: ACTIVE_COMPARATOR

Placebo in combination with metformin

Intervention Type: DRUG

placebo will be administerd for 14 days, 1 cp after lunch and 1 cp after dinner in addition to pre-existing metformin therapy

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Silvia Manfrini

Prof., MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, RM, Italy

Countries

Italy

Other Identifiers

The DIACHIRO Study

Identifier Type: -

Identifier Source: org_study_id