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

NCT00943865 | Completed

• 2 other identifiers: 07033GPPG07033 HCPA FIPE
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Obesity

Keywords

metabolic syndrome; lifestyle; exercise; endothelial dysfunction; insulin sensitivity; lipids

Outcome Measures

Primary Outcomes (1)

• endothelial mediated vasodilation

  at enrollment, after 6 and after 12 weeks

Secondary Outcomes (1)

• weight

  randomization, 6 and 12 weeks

Study Arms (3)

hypocaloric diet + exercise advice

ACTIVE COMPARATOR

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.

Behavioral: hypocaloric diet; Behavioral: Exercise recommendations

pragmatic diet+ pedometer 10000 steps

EXPERIMENTAL

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.

Behavioral: Pragmatic diet; Behavioral: Pedometer-based fitness (10,000 steps)

pragmatic diet + fitness

EXPERIMENTAL

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.

Behavioral: Pragmatic diet; Behavioral: Structured assisted exercise (fitness)

Interventions

hypocaloric diet BEHAVIORAL

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.

hypocaloric diet + exercise advice

Exercise recommendations BEHAVIORAL

Exercise was advised but not measured: they received recommendations to be physically active and perform 1 hour of aerobic exercise as preferred, everyday.

hypocaloric diet + exercise advice

Pragmatic diet BEHAVIORAL

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.

pragmatic diet + fitness; pragmatic diet+ pedometer 10000 steps

Pedometer-based fitness (10,000 steps) BEHAVIORAL

Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.

pragmatic diet+ pedometer 10000 steps

Structured assisted exercise (fitness) BEHAVIORAL

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

pragmatic diet + fitness

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Beatriz G Seligman, MD MsC

  Serviço de Medicina Interna Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: July 22, 2009

Record last verified: 2009-07

Locations

BR (1)