Skip to main content
OpenTrials
Completed

NCT Number: NCT03035149

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Dyspnea Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Management Program

Other

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Collaborators

  • Ontario Lung Association
  • The Ottawa Hospital

Registry information

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2017
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.