Clinical trial

Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk Factors (KETOHEART)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05781269

Active, not recruitingNot applicableInterventional

What this study is about

The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system. Numerous scientific evidences have demonstrated that a moderate weight loss (5-10% of the initial body weight) is already sufficient to determine the improvement of the cardiometabolic risk factors associated with overweight and obesity. With a view to obtaining a more significant weight loss in the initial stages of dietary treatment, in the last 10 years, the very low-calorie ketogenic diet (VLCKD) has become a strategy for the treatment of obesity and its comorbidities, also allowing to limit therapeutic failure and the high drop-out typical of traditional low-calorie diets. The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome compared to a restrictive Mediterranean diet. One hundred subjects with severe obesity and metabolic syndrome will be recruited and randomly assigned to VLCKD or to restrictive Mediterranean diet. Anthropometric parameters, metabolic status blood pressure, degree of arterial stiffness, prevalence and severity of snoring and OSA, cardiac systolic and diastolic function, the autonomic nervous control mode of the circulation will be evaluated at baseline, after one month and at the end of the study.

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

Age55 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Morbid Obesity

Full registry 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

Treatments and study arms

VLCKD

Other

VLCKD diet treatment with medical food

r-MedDiet

Other

Mediterranean diet treatment

Primary outcomes

change from baseline body weight at 36 monthsbaseline, 36 month

body weight measured to the nearest 0.1 Kg with a calibrated weight scale

change from baseline fasting glucose in mg/dl at 36 monthsbaseline, 36 month

blood chemistry tests for the evaluation of blood glucose

change from baseline HDL cholesterol, triglycerides at 36 monthsbaseline, 36 month

blood chemistry tests for the evaluation of HDL cholesterol, triglycerides

change from baseline blood pressure in mmHg at 36 monthsbaseline, 36 months

measurement of systolic and diastolic pressure using using an aneroid sphygmomanometer with the appropriate cuff

change from baseline distensibility of the carotid, radial and femoral arteries in m/s at 36 monthsbaseline, 36 months

arterial stiffness measured by Pulse Wave Velocity carotid-femoral

change from baseline waist circumference in cm at 36 monthsbaseline, 36 months

waist circumference using a non-stretch tape to the nearest 0.5 cm

Study locations

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

Istituto Auxologico Italiano🇮🇹 Milan, Italy

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