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NCT Number: NCT06860841

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight and Obese Adults Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, RM, 00128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Significant renal or hepatic impairment (eGFR <60 mL/min/1.73 m²; ALT/AST >2× ULN).
  • Pregnancy or lactation.

Treatment and study plan

D-Chiro-Inositol Combined with Metformin

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

Placebo in combination with metformin

Drug

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

Primary outcomes

  1. Change in the HOMA index

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

    fasting glucose and insulin will be measured

Secondary outcomes

  1. 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 %)

  2. Changes in oxidative stress markers

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

    D-ROM PAT

  3. Indirect calorimetry measurements

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

    Indirect calorimetry measurements

  4. Respiratory quotient measurements.

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

    Respiratory quotient measurements.

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: DIACHIRO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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