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Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs

NCT ID: NCT00929890

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-03-31

Brief Summary

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This study tests the hypothesis that exercise training can confer additional benefit to patients in weight-loss programs in the form of improvements in either metabolic or vascular parameters or both. Patients will be randomized to either diet plus conventional physical activity or diet plus a planned exercise training. The interventions will be carried out until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end, all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin, c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and abdominal visceral fat (CT-scan). Both groups will be compared.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

Patients will receive dietary counseling and a general advice on physical activity

Group Type ACTIVE_COMPARATOR

General lifestyle, diet and physical activity counselling

Intervention Type BEHAVIORAL

Low-calorie, balanced diet and a general advice on the importance of regular physical activity

Exercise training

patients will receive dietary counseling and will be enrolled in supervised exercise training

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program

Interventions

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General lifestyle, diet and physical activity counselling

Low-calorie, balanced diet and a general advice on the importance of regular physical activity

Intervention Type BEHAVIORAL

Exercise training

Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI\> 30 and \<40

Exclusion Criteria

* Diabetes mellitus
* Active endocrine disease
* Active heart disease
* Active smoking
* Medical contra-indications for exercise
* Using anti-obesity drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rogério Friedman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Lopes AL, Macedo RCO, Kruger RL, Friedman R, Carteri RB, Reischak-Oliveira A. Fasted exercise does not improve postprandial lipemia responses to different meals in lean and obese subjects: A crossover, randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:160-167. doi: 10.1016/j.clnesp.2020.11.013. Epub 2020 Dec 30.

Reference Type DERIVED
PMID: 33487260 (View on PubMed)

Other Identifiers

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08282

Identifier Type: -

Identifier Source: org_study_id