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Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss

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ClinicalTrials.gov Identifier: NCT03035149
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Ontario Lung Association
The Ottawa Hospital
Information provided by (Responsible Party):
Dr. Nha Voduc, University of Ottawa

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.


Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Other: Weight Management Program Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
Study Start Date : May 2005
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weight Management Program
Obese subjects participate in a year long medically supervised weight management program.
Other: Weight Management Program
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.

No Intervention: Normal Weight Controls
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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035149


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
University of Ottawa
Ontario Lung Association
The Ottawa Hospital
Investigators
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Principal Investigator: Nha Voduc, MD University of Ottawa

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Responsible Party: Dr. Nha Voduc, MD, University of Ottawa
ClinicalTrials.gov Identifier: NCT03035149     History of Changes
Other Study ID Numbers: 2005213-01H
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Nha Voduc, University of Ottawa:
Obesity
Metabolic Syndrome
Dyspnea
Pulmonary Function
Exercise Capacity

Additional relevant MeSH terms:
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Dyspnea
Metabolic Syndrome
Syndrome
Weight Loss
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory