Overweight and Obese Adults, Type 2 Diabetes
Conditions
Keywords
D-Chiro-Inositol, Type 2 Diabetes Mellitus, Insulin Resistance, Metformin, Glycemic Variability
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.
Detailed 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.
Interventions
DRUGD-Chiro-Inositol Combined with Metformin
D-chiro-Inositol will be administered for 14 days,1 cp after lunch and 1 cp after dinner in addition to preexisting metformin therapy
DRUGPlacebo in combination with metformin
placebo will be administerd for 14 days, 1 cp after lunch and 1 cp after dinner in addition to pre-existing metformin therapy
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the HOMA index | at the end of treatment phase (two weeks) | fasting glucose and insulin will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range in % | at the end of treatment (two weeks) | Time in range in % (time spent with a glucose level between 70-180 mg/dL expressed in %) |
| Changes in oxidative stress markers | at the end of treatment (two weeks) | D-ROM PAT |
| Indirect calorimetry measurements | at the end of treatment (two weeks) | Indirect calorimetry measurements |
| Respiratory quotient measurements. | at the end of treatment (two weeks) | Respiratory quotient measurements. |
Countries
Italy
Outcome results
None listed