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

NCT03035149 | Completed

• 1 other identifier: 2005213-01H
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Dyspnea (measured by Transitional Dyspnea Index)

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

  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

  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

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

Study Arms (2)

Weight Management Program

EXPERIMENTAL

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

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.

Interventions

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.

Weight Management Program

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead
• Ontario Lung Association: collaborator
• The Ottawa Hospital: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Nha Voduc, MD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 27, 2017
• Study Start: May 1, 2005
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)