Clinical trial

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

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT06860841

Active, not recruitingPhase 4Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Overweight and Obese Adults

Full registry 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.

Treatments and study arms

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

Change in the HOMA indexat the end of treatment phase (two weeks)

fasting glucose and insulin will be measured

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Fondazione Policlinico Universitario Campus Bio-Medico🇮🇹 Rome, RM, Italy

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