Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT05781269
Eligibility Criteria:
Inclusion Criteria:
* Men between the ages of 55 and 75 with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
* Women aged 60 to 75, with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
* BMI ≥30 and \<50kg/m2-At least three positive factors for metabolic syndrome according to the harmonized definition (IDF --------2009)
* Availability to be followed in the follow-up at the San Michele Hospital IRCCS Istituto Auxologico Italiano in Milan
Exclusion Criteria:
* Long QT \>0.44 s, known arrhythmia, cardiomyopathy, heart failure (NYHA classes III-IV)
* Hypokalemia, hypernatremia
* Persistent diarrhea
* Acidosis (metabolic or respiratory) even if compensated
* Acute heart failure, transient ischemic attack or stroke in the previous 12 months
* Pregnancy or breastfeeding
* chronic renal insufficiency (creatinine \>1.5 and/or creatinine clearance \<45 mL/min), history -positive for previous episodes of acute renal failure
* Autoimmune diseases (TCA relative contraindication)
* History of previous pancreatitis
* Symptomatic cholelithiasis
* Hepatic insufficiency and/or ALT and AST \> 3 times the upper limit
* Stubborn constipation or history of intestinal occlusions/subocclusions
* Type 1 diabetes
* History of previous cancer within the first 5 years of follow-up
* Active eating disorder or history of bulimia and anorexia nervosa, active severe binge eating,
* Psychiatric disorders not in compensation or at risk of decompensation
* Alcoholism, substance abuse
* Ongoing pharmacological therapy with topiramate, zonisamide, acetazolamide, valproic acid- - ----- - chronic therapy with diuretics (which cannot be suspended even temporarily), SGLT2 -inhibitors (due to the risk of euglycemic diabetic ketoacidosis) and beta blockers.
* Known primary pathologies of carnitine metabolism or beta oxidation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT05781269
Study Brief:
Protocol Section:
NCT05781269