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

Phase 4Active Not RecruitingNCT06860841

Campus Bio-Medico University16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Overweight and Obese Adults

Interventions

D-Chiro-Inositol Combined with MetforminDRUG

D-chiro-Inositol will be administered for 14 days,1 cp after lunch and 1 cp after dinner in addition to preexisting metformin therapy

Placebo in combination with metforminDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, RM, Italy

Outcomes

Primary Outcomes

Change in the HOMA index

fasting glucose and insulin will be measured

Time frame: at the end of treatment phase (two weeks)

Secondary Outcomes

Time in Range in %

Time in range in % (time spent with a glucose level between 70-180 mg/dL expressed in %)

Time frame: at the end of treatment (two weeks)

Changes in oxidative stress markers

D-ROM PAT

Time frame: at the end of treatment (two weeks)

Indirect calorimetry measurements

Time frame: at the end of treatment (two weeks)

Respiratory quotient measurements.

Time frame: at the end of treatment (two weeks)

Data from ClinicalTrials.gov

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