ObesityNCT00929890
Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs
A study testing General lifestyle, diet and physical activity counselling and Exercise training in people with Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- General lifestyle, diet and physical activity counselling and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI> 30 and <40
Who cannot join
- Diabetes mellitus
- Active endocrine disease
- Active heart disease
- Active smoking
- Medical contra-indications for exercise
- Using anti-obesity drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
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.
- Conditions
- Obesity
- Being tested
- General lifestyle, diet and physical activity counselling, Exercise training
- Keywords
- Obesity, Exercise, Diet, Lifestyle, Vascular reactivity, Body composition, Lipids, Glucose, Insulin resistance
- Medical subject headings
- Obesity, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General lifestyle, diet and physical activity counsellingBehavioural
Low-calorie, balanced diet and a general advice on the importance of regular physical activity
Exercise trainingBehavioural
Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | Patients will receive dietary counseling and a general advice on physical activity Receives: Behavioral: General lifestyle, diet and physical activity counselling |
| Exercise training | Experimental | patients will receive dietary counseling and will be enrolled in supervised exercise training Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 6 months
Change in lipid profile
Measured: 6 months
Reduction in abdominal (visceral) fat
Measured: 6 months
Change in vascular reactivity
Measured: 6 months
Secondary outcomes (4)
C-reactive protein
Measured: 6 months
Fibrinogen
Measured: 6 months
vonWillebrand factor
Measured: 6 months
Waist circumference
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rogério Friedman, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929890
- Sponsor's protocol ID
- 08282
- Status last verified
- Jul 2011
- First submitted
- 29 Jun 2009
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33487260
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT00929890
- Acronym / sponsor ID
- 08282
- Conditions
- Obesity
- Keywords
- Obesity, Exercise, Diet, Lifestyle, Vascular reactivity, Body composition, Lipids, Glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: General lifestyle, diet and physical activity counsellingPatients will receive dietary counseling and a general advice on physical activity |
| Exercise training | Experimental | Behavioral: Exercise trainingpatients will receive dietary counseling and will be enrolled in supervised exercise training |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI> 30 and <40
Key exclusion criteria (6 listed)
- Diabetes mellitus
- Active endocrine disease
- Active heart disease
- Active smoking
- Medical contra-indications for exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General lifestyle, diet and physical activity counsellingLow-calorie, balanced diet and a general advice on the importance of regular physical activity | Behavioural | Lifestyle counseling |
| Exercise trainingSubject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program | Behavioural | Exercise training |
Primary outcome
Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 6 months
Change in lipid profile
Time frame: 6 months
Reduction in abdominal (visceral) fat
Time frame: 6 months
Change in vascular reactivity
Time frame: 6 months
4 secondary outcomes
C-reactive protein
Time frame: 6 months
Fibrinogen
Time frame: 6 months
vonWillebrand factor
Time frame: 6 months
Waist circumference
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Derived from this study: PubMed 33487260Lopes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogério Friedman, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General lifestyle, diet and physical activity counselling and Exercise training in people with Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in homeostasis model assessment of insulin resistance (HOMA-IR) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.