Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk F… (NCT05781269) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk Factors (KETOHEART)
Italy100 participantsStarted 2022-02-20
Plain-language summary
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.
Who can participate
Age range
55 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 no…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change from baseline body weight at 36 months
Timeframe: baseline, 36 month
2
change from baseline fasting glucose in mg/dl at 36 months
Timeframe: baseline, 36 month
3
change from baseline HDL cholesterol, triglycerides at 36 months
Timeframe: baseline, 36 month
4
change from baseline blood pressure in mmHg at 36 months
Timeframe: baseline, 36 months
5
change from baseline distensibility of the carotid, radial and femoral arteries in m/s at 36 months
Timeframe: baseline, 36 months
6
change from baseline waist circumference in cm at 36 months