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

Campus Bio-Medico University of Rome

Status and phase: Active, not recruiting; Phase 4

Conditions: Type 2 Diabetes; Overweight and Obese Adults

Treatments: Drug: Placebo in combination with metformin; Drug: D-Chiro-Inositol Combined with Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06860841

The DIACHIRO Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Experimental Intervention/Treatment

Experimental group

Description:

D-Chiro-Inositol in combination with metformin

Treatment:

Drug: D-Chiro-Inositol Combined with Metformin

Active Comparator Intervention/Treatment

Active Comparator group

Description:

Placebo in combination with metformin

Treatment:

Drug: Placebo in combination with metformin