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Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00943865
First received: July 20, 2009
Last updated: July 21, 2009
Last verified: July 2009

July 20, 2009
July 21, 2009
June 2007
December 2008   (final data collection date for primary outcome measure)
endothelial mediated vasodilation [ Time Frame: at enrollment, after 6 and after 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00943865 on ClinicalTrials.gov Archive Site
weight [ Time Frame: randomization, 6 and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome
Effect of Three Lifestyle Interventions on Endothelial Function, Anthropometric Parameters and Cardiometabolic Profile in Obese Patients With Metabolic Syndrome: a Randomized Controlled Trial .

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Obesity
  • Behavioral: hypocaloric diet
    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.
  • Behavioral: Exercise recommendations
    Exercise was advised but not measured: they received recommendations to be physically active and perform 1 hour of aerobic exercise as preferred, everyday.
  • Behavioral: Pragmatic diet
    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.
  • Behavioral: Pedometer-based fitness (10,000 steps)
    Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.
  • Behavioral: Structured assisted exercise (fitness)
    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
  • Active Comparator: hypocaloric diet + exercise advice
    Group 1 (control: tailored hypocaloric diet and exercise advised): 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.
    Interventions:
    • Behavioral: hypocaloric diet
    • Behavioral: Exercise recommendations
  • Experimental: pragmatic diet+ pedometer 10000 steps
    Group 2 (pragmatic diet + step counter) - 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.
    Interventions:
    • Behavioral: Pragmatic diet
    • Behavioral: Pedometer-based fitness (10,000 steps)
  • Experimental: pragmatic diet + fitness
    Group 3 (pragmatic diet + fitness) - They received the same diet intervention (low carbohydrates, high protein and vegetables style diet and favoring daily brazilian cook habits colored handbook) and hand sized portion control instructions of group 2. 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.
    Interventions:
    • Behavioral: Pragmatic diet
    • Behavioral: Structured assisted exercise (fitness)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00943865
07033, GPPG07033 HCPA FIPE
No
Beatriz Graeff Santos Seligman/ professor Serviço de Medicina Interna, Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Principal Investigator: Beatriz G Seligman, MD MsC Serviço de Medicina Interna Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP