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

Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00929890

Enrollment

Registered

2009-06-30

Start date

2009-02-28

Completion date

2012-03-31

Last updated

2011-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Exercise, Diet, Lifestyle, Vascular reactivity, Body composition, Lipids, Glucose, Insulin resistance

Brief summary

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.

Interventions

BEHAVIORALGeneral lifestyle, diet and physical activity counselling

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

BEHAVIORALExercise training

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in vascular reactivity	6 months
Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)	6 months
Change in lipid profile	6 months
Reduction in abdominal (visceral) fat	6 months

Secondary

Measure	Time frame
C-reactive protein	6 months
Fibrinogen	6 months
vonWillebrand factor	6 months
Waist circumference	6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026