Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Obese patients with metabolic syndrome without diabetes or ischemic heart disease were
      randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard
      recommendations 2. pragmatic healthy style diet adapted to brazilian habits with portion
      control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style
      diet adapted to brazilian habits with portion control plus fitness three times a week under
      direct supervision. The main outcome was brachial reactivity, a surrogate marker of
      atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and
      anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat
      proportion and insulin sensitivity.
    

Detailed description: 
      It's a 12 week single center randomized controlled trial to evaluate three different
      lifestyle interventions on flow mediated vasodilatation, cardiometabolic profile and
      anthropometric parameters in non-diabetic persons with metabolic syndrome without coronary
      heart disease.

      After informed consent, they will be randomized to 3 different lifestyle interventions: 1.
      Hypocaloric tailored AHA type 1 diet plus standard exercise advice; 2. Pragmatic portion
      controlled healthy diet plus pedometers to perform 10.000 steps daily or 3. pragmatic portion
      controlled healthy diet plus fitness under direct supervision,using heart rate monitors to
      adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate -
      HRpeak, as determined by their individual maximal treadmill exercise test).Main outcome is
      endothelium vasodilation accessed through brachial ultrasound, a surrogate marker of
      atherosclerosis. Secondary outcomes are anthropometric data: weight, waist circumference and
      fat proportion, cardiometabolic profile and insulin sensitivity (HOMA-R).
    

Intervention name(s): hypocaloric diet; Exercise recommendations; Pragmatic diet; Pedometer-based fitness (10,000 steps); Structured assisted exercise (fitness)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): patients received individually tailored hypocaloric diet, with 20% of total calories as fat (with 7-8 % of saturated fats), 50 to 65% carbohydrates and 15% to 20% proteins. Total of calories for each patient calculated assuming the ideal body weight to fulfill a BMI of 25 kg⁄ M2. Total daily amount of calories estimated calculating 30 calories/Kg of ideal weight for each subject. Subjects were advised against consuming high fat snacks or additional fats. Alimentary plans specified the number of servings from each food group, and dairy intake was held constant.; Exercise was advised but not measured: they received recommendations to be physically active and perform 1 hour of aerobic exercise as preferred, everyday.; Patients received a portable colored handbook with evidence- based recommendations on healthy eating attitudes and pragmatic menus, with low carbohydrates and high protein and vegetables. It included controlled portions (adjusted for individual hand size) for the six meals, with low glucose aliments and whole grains, legumes, yogurt, fruits, olive oils, eggwhite and low fat milk, fiber and a handful of nuts. Portions were tailored according to individual hand size, without calories counting. Beans, farofa and white cheese bread, which are commonly present in Brazilian food, and red meat were allowed, but with portion control.; Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.; They were scheduled for a more structured assisted exercise intervention: three bicycle ergometer sessions per week, under direct supervision of the same trained exercise physiologists in each session. Heart rate monitors were used to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate), as determined by their individual maximal treadmill exercise test. All patients were trained by the same staff, Borg scale was registered in every session and persuasive goal setting was made during exercise sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: metabolic syndrome; lifestyle; exercise; endothelial dysfunction; insulin sensitivity; lipids