Clinical trial NCT00943865: Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome
Official title: Effect of Three Lifestyle Interventions on Endothelial Function, Anthropometric Parameters and Cardiometabolic Profile in Obese Patients With Metabolic Syndrome: a Randomized Controlled Trial .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: metabolic syndrome
lifestyle
exercise
endothelial dysfunction
insulin sensitivity
lipids
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* men and women 30-55 years with BMI 30-40 and waist 95 cm or more
* normal OGTT
* normal treadmill stress test
* plus 2 of 4:

  1. low serum levels of HDL cholesterol (\<40 mg⁄dL for men or \< 50 mg ⁄dL for women);
  2. hypertriglyceridemia (triglyceride levels of 150 mg⁄dL or greater);
  3. impaired glucose homeostasis (fasting plasma glucose concentration of 110 mg⁄dL or greater or glucose of 140 mg⁄dL or greater after OGTT or
  4. hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥90 mmHg or treatment with antihypertensive drugs).

Exclusion Criteria:

* diabetes
* ischemic heart disease or any abnormality on treadmill stress test
* inflammatory or chronic disorder
* pregnancy
* lactation
* creatinine level of 1,5 mg/dL or more
* gastrointestinal problems or musculoskeletal disorders that would prevent them to follow the test diets or exercise interventions
* liver dysfunction with a factor of at least 3 above the upper limit of normal in AST and ALT levels
* thyroid dysfunction, with serum TSH out of normal limits
* use of immunosuppressive drugs, corticosteroids or anorexigen

Primary outcomes:
measure: endothelial mediated vasodilation
timeFrame: at enrollment, after 6 and after 12 weeks
Secondary outcomes:
measure: weight
timeFrame: randomization, 6 and 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Serviço de Medicina Interna Hospital de Clinicas de Porto Alegre
name: Beatriz G Seligman, MD MsC
role: PRINCIPAL_INVESTIGATOR
References: