ObesityNCT03035149
Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
A study testing Weight Management Program in people with Obesity and Metabolic Syndrome, run by University of Ottawa at 1 site in Canada.
Trial summary
Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the effects of weight loss on dyspnea are not completely understood. The objectives of this study were to examine the relationships between exercise parameters and dyspnea in obesity and assess the effects of weight loss. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Weight Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals accepted into the behavioural weight management program at the Ottawa Hospital Bariatric Centre
- Age between 20 and 60 years
- BMI greater than 30
- Abdominal girth (for females) greater than 88 cm
- Abdominal girth (for males) greater than 102 cm
- Plus any two of the other criteria for Metabolic Syndrome:
- i.e. Blood Pressure greater or equal to 130/85; Fasting Glucose greater or equal to 6.1 mmol/L
- Controls-normal weight (NW) and sedentary
Who cannot join
- Smoker
- Any medical conditions which would affect exercise performance
- Use of medications that could affect exercise performance (i.e. Beta-blockers)
- Inability to pedal on a cycle ergometer and provide reproducible inspiratory capacity (IC) measurements
Trial locations and contacts
1 site in 1 country.
About this study
Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the effects of weight loss on dyspnea are not completely understood. The objectives of this study were to examine the relationships between exercise parameters and dyspnea in obesity and assess the effects of weight loss.
The investigators compared pulmonary function, exercise performance and dyspnea in 34 patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched controls. The study also assessed within-group changes in physiology and symptoms in a subset of patients following participation in a weight management program.
Because obesity is a heterogeneous condition, with variable genetic associations, co-morbidities and distributions of adipose tissue, the study focused on patients with abdominal obesity who met diagnostic criteria for metabolic syndrome.
Read the detailed description
The study has two parts: first, the investigators compared dyspnea, pulmonary function and exercise measurements between obese patients and control subjects with normal weight; then, the investigators assessed the effects of medical weight loss in the obese group on these parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of weight loss on dyspnea was assessed using the transitional dyspnea index. The main physiologic measurement of interest was the inspiratory capacity (L, measured at rest and during exercise).
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Weight Management Program
- Keywords
- Obesity, Metabolic Syndrome, Dyspnea, Pulmonary Function, Exercise Capacity
- Medical subject headings
- Obesity, Metabolic Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Management ProgramOther
Obese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Weight Management Program | Experimental | Obese subjects participate in a year long medically supervised weight management program. Receives: Other: Weight Management Program |
| Normal Weight Controls | No intervention | Normal weight age and sex-matched controls. Unlike the obese subjects, the controls did not participate in the Weight Management Program. Pulmonary function, exercise performance and dyspnea results for normal weight controls were compared against the results for obese subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea (measured by Transitional Dyspnea Index)
Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index
Measured: Within 6 months following completion of 6 months (weight loss period) in the weight management program
Resting Inspiratory Capacity (L)
Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest
Measured: Within 6 months following completion of 6 months (weight loss period) in the weight management program
Inspiratory Capacity during Exercise (L)
Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss
Measured: Within 6 months following completion of 6 month (weight loss period) in the weight management program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startMay 2005
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association, The Ottawa Hospital
- Responsible party
- Principal investigator, Dr. Nha Voduc, University of Ottawa
- Investigators
- Nha Voduc, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035149
- Sponsor's protocol ID
- 2005213-01H
- Status last verified
- Mar 2018
- First submitted
- 24 Jan 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
- ClinicalTrials.gov ID
- NCT03035149
- Acronym / sponsor ID
- 2005213-01H
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Obesity, Metabolic Syndrome, Dyspnea, Pulmonary Function, Exercise Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Ontario Lung Association, The Ottawa Hospital
- Study start
- May 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Jan 2017 (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.
Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the effects of weight loss on dyspnea are not completely understood. The objectives of this study were to examine the relationships between exercise parameters and dyspnea in obesity and assess the effects of weight loss.
The investigators compared pulmonary function, exercise performance and dyspnea in 34 patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched controls. The study also assessed within-group changes in physiology and symptoms in a subset of patients following participation in a weight management program.
Because obesity is a heterogeneous condition, with variable genetic associations, co-morbidities and distributions of adipose tissue, the study focused on patients with abdominal obesity who met diagnostic criteria for metabolic syndrome.
Detailed description
The study has two parts: first, the investigators compared dyspnea, pulmonary function and exercise measurements between obese patients and control subjects with normal weight; then, the investigators assessed the effects of medical weight loss in the obese group on these parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of weight loss on dyspnea was assessed using the transitional dyspnea index. The main physiologic measurement of interest was the inspiratory capacity (L, measured at rest and during exercise).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Management Program | Experimental | Other: Weight Management ProgramObese subjects participate in a year long medically supervised weight management program. |
| Normal Weight Controls | No intervention | –Normal weight age and sex-matched controls. Unlike the obese subjects, the controls did not participate in the Weight Management Program. Pulmonary function, exercise performance and dyspnea results for normal weight controls were compared against the results for obese subjects. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Individuals accepted into the behavioural weight management program at the Ottawa Hospital Bariatric Centre
- Age between 20 and 60 years
- BMI greater than 30
- Abdominal girth (for females) greater than 88 cm
- Abdominal girth (for males) greater than 102 cm
Key exclusion criteria (4 listed)
- Smoker
- Any medical conditions which would affect exercise performance
- Use of medications that could affect exercise performance (i.e. Beta-blockers)
- Inability to pedal on a cycle ergometer and provide reproducible inspiratory capacity (IC) measurements
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 |
|---|---|---|
| Weight Management ProgramObese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks. | Other | Weight Management Program |
Primary outcome
Dyspnea (measured by Transitional Dyspnea Index)
Time frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program
Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index
Resting Inspiratory Capacity (L)
Time frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program
Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest
Inspiratory Capacity during Exercise (L)
Time frame: Within 6 months following completion of 6 month (weight loss period) in the weight management program
Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Nha Voduc, MD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Management Program in people with Obesity and Metabolic Syndrome, run by University of Ottawa at 1 site in Canada.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2018. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dyspnea (measured by Transitional Dyspnea Index) (time frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2018.