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

Primary Purpose

Metabolic Syndrome, Obesity

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

hypocaloric diet

Exercise recommendations

Pragmatic diet

Pedometer-based fitness (10,000 steps)

Structured assisted exercise (fitness)

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, lifestyle, exercise, endothelial dysfunction, insulin sensitivity, lipids

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

hypocaloric diet + exercise advice

pragmatic diet+ pedometer 10000 steps

pragmatic diet + fitness

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

endothelial mediated vasodilation

Secondary Outcome Measures

weight

Full Information

NCT ID

NCT00943865

First Posted

July 20, 2009

Last Updated

July 21, 2009

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT00943865

Brief Title

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

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

hypocaloric diet + exercise advice

Arm Type

Active Comparator

Arm Description

Arm Title

pragmatic diet+ pedometer 10000 steps

Arm Type

Experimental

Arm Description

Arm Title

pragmatic diet + fitness

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

hypocaloric diet

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exercise recommendations

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Pragmatic diet

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Pedometer-based fitness (10,000 steps)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Structured assisted exercise (fitness)

Intervention Description

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

Primary Outcome Measure Information:

Title

endothelial mediated vasodilation

Time Frame

at enrollment, after 6 and after 12 weeks

Secondary Outcome Measure Information:

Title

weight

Time Frame

randomization, 6 and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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: 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). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatriz G Seligman, MD MsC

Organizational Affiliation

Serviço de Medicina Interna Hospital de Clinicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clinicas de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90035903

Country

Brazil

12. IPD Sharing Statement

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

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