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

Obesity Clinical Trial

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943865
• Other study ID #: 07033
• Secondary ID: GPPG07033 HCPA F
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: July 21, 2009
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

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.
• 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.
• 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.
• Pedometer-based fitness (10,000 steps)
Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial mediated vasodilation		at enrollment, after 6 and after 12 weeks	No
Secondary	weight		randomization, 6 and 12 weeks	No