NCT00929890

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 26, 2011

Status Verified

July 1, 2011

Enrollment Period

3.1 years

First QC Date

June 29, 2009

Last Update Submit

October 25, 2011

Conditions

Obesity

Keywords

ObesityExerciseDietLifestyleVascular reactivityBody compositionLipidsGlucoseInsulin resistance

Outcome Measures

Primary Outcomes (4)

  • 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

  • Change in vascular reactivity

    6 months

Secondary Outcomes (4)

  • C-reactive protein

    6 months

  • Fibrinogen

    6 months

  • vonWillebrand factor

    6 months

  • Waist circumference

    6 months

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

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

Behavioral: General lifestyle, diet and physical activity counselling

Exercise training

EXPERIMENTAL

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

Behavioral: Exercise training

Interventions

General lifestyle, diet and physical activity counsellingBEHAVIORAL

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

Lifestyle counseling
Exercise trainingBEHAVIORAL

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

Exercise training

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\> 30 and \<40

You may not qualify if:

  • Diabetes mellitus
  • Active endocrine disease
  • Active heart disease
  • Active smoking
  • Medical contra-indications for exercise
  • Using anti-obesity drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 33487260DERIVED

MeSH Terms

Conditions

ObesityMotor ActivityInsulin Resistance

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rogério Friedman, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 26, 2011

Record last verified: 2011-07

Locations

BR(1)