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

Primary Purpose

Obesity, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Weight Management Program

About this trial

This is an interventional health services research trial for Obesity focused on measuring Obesity, Metabolic Syndrome, Dyspnea, Pulmonary Function, Exercise Capacity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Weight Management Program

Normal Weight Controls

Arm Description

Obese subjects participate in a year long medically supervised weight management program.

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.

Outcomes

Primary Outcome Measures

Dyspnea (measured by Transitional Dyspnea Index)

Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index

Resting Inspiratory Capacity (L)

Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest

Inspiratory Capacity during Exercise (L)

Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss

Secondary Outcome Measures

Full Information

NCT ID

NCT03035149

First Posted

January 24, 2017

Last Updated

March 2, 2018

Sponsor

University of Ottawa

Collaborators

Ontario Lung Association, The Ottawa Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03035149

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ottawa

Collaborators

Ontario Lung Association, The Ottawa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome

Keywords

Obesity, Metabolic Syndrome, Dyspnea, Pulmonary Function, Exercise Capacity

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Management Program

Arm Type

Experimental

Arm Description

Obese subjects participate in a year long medically supervised weight management program.

Arm Title

Normal Weight Controls

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Weight Management Program

Intervention Description

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 Outcome Measure Information:

Title

Dyspnea (measured by Transitional Dyspnea Index)

Description

Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index

Time Frame

Within 6 months following completion of 6 months (weight loss period) in the weight management program

Title

Resting Inspiratory Capacity (L)

Description

Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest

Time Frame

Within 6 months following completion of 6 months (weight loss period) in the weight management program

Title

Inspiratory Capacity during Exercise (L)

Description

Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss

Time Frame

Within 6 months following completion of 6 month (weight loss period) in the weight management program

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nha Voduc, MD

Organizational Affiliation

University of Ottawa

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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