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

NCT06860841 | Active Not Recruiting Phase 4

• 1 other identifier: The DIACHIRO Study
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Overweight and Obese Adults

Keywords

D-Chiro-Inositol; Type 2 Diabetes Mellitus; Insulin Resistance; Metformin; Glycemic Variability

Outcome Measures

Primary Outcomes (1)

• Change in the HOMA index

  fasting glucose and insulin will be measured

  at the end of treatment phase (two weeks)

Secondary Outcomes (4)

• Time in Range in %

  at the end of treatment (two weeks)

• Changes in oxidative stress markers

  at the end of treatment (two weeks)

• Indirect calorimetry measurements

  at the end of treatment (two weeks)

• Respiratory quotient measurements.

  at the end of treatment (two weeks)

Study Arms (2)

Experimental Intervention/Treatment

EXPERIMENTAL

D-Chiro-Inositol in combination with metformin

Drug: D-Chiro-Inositol Combined with Metformin

Active Comparator Intervention/Treatment

ACTIVE COMPARATOR

Placebo in combination with metformin

Drug: Placebo in combination with metformin

Interventions

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

Experimental Intervention/Treatment

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

Active Comparator Intervention/Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, RM, 00128, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 6, 2025
• Study Start: January 10, 2025
• Primary Completion: February 10, 2025
• Study Completion: April 10, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)