Clinical trial NCT03035149: Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
Official title: Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: Obesity
Metabolic Syndrome
Dyspnea
Pulmonary Function
Exercise Capacity
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
name: The Ottawa Hospital
First posted: 2017-01-27
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dyspnea (measured by Transitional Dyspnea Index)
timeFrame: Within 6 months following completion of 6 months (weight loss period) in the weight management program
measure: Resting Inspiratory Capacity (L)
timeFrame: Within 6 months following completion of 6 months (weight loss period) in the weight management program
measure: Inspiratory Capacity during Exercise (L)
timeFrame: Within 6 months following completion of 6 month (weight loss period) in the weight management program
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Nha Voduc, MD
role: PRINCIPAL_INVESTIGATOR
References: