- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06054594
Resistance Training and Cardiometabolic Risk
November 27, 2023 updated by: Antony Karelis, Université du Québec a Montréal
Resistance Training and Cardiometabolic Risk in Women With Metabolically Healthy and Unhealthy Obesity
Little is known on the effects of resistance training (RT) alone in individuals with metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO).
The present study aimed to examine the impact of RT on body composition, physical performance, lipid-lipoprotein profile, inflammation, and glucose-insulin homeostasis in 51 sedentary, postmenopausal women categorized as MHO vs MUHO, according to the Karelis and Rabasa- Lhoret classification or a single-phenotype adiposopathy approach (the plasma adiponectin (A)/leptin (L) ratio).
Participants followed a 4-month weekly RT program of 3 non-consecutive days of 6 exercises of major muscle groups (3 sets of 10 repetitions at 80% 1-RM).
Study Overview
Detailed Description
Several studies have examined MHO individuals' responses to weight loss interventions.
Caloric restriction decreases body weight and body fat, notably visceral fat accumulation, of both MHO and MUHO pre- and postmenopausal women, although changes in MUHO women are usually more important.
In addition, while insulin sensitivity of MUHO women increases after a 12-week diet, it is significantly worsened in postmenopausal MHO women.
In this regard, previous works have shown discordant data of interventions including physical activity on the cardiometabolic risk and more particularly, insulin sensitivity.
Indeed, diet or aerobic training alone or combined aerobic and resistance training (RT), in men and postmenopausal women yielded promising results as insulin sensitivity increased in both MUHO and MHO participants, with greater changes in the MUHO groups.
However, the heterogeneity of the population (analysis without considering sex differences) as well as the type and duration (3 to 6 months) of different interventions make it difficult to generalize these results.
As an example, insulin sensitivity was improved in MUHO men and women, while it remained unchanged in MHO participants after a 9-month intervention combining diet and exercise.
Moreover, a 14-week community-based aerobic exercise program increased participants' cardiorespiratory fitness and reduced the number of metabolic syndrome components of MHO men and women.
However, to the best of our knowledge, no study has compared yet the impact of a RT program on MUHO and MHO individuals.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- cessation of menstruation for more than 1 year and a follicle-stimulating hormone level ≥ 30 IU/L
- sedentary for at least 3 months (< 2 h/week of structured exercise)
- non-smokers
- free of known inflammatory diseases
- no use of hormone replacement therapy
- body mass index ≥ 30 kg/m2
- low to moderate alcohol consumption (< 2 drinks/day)
Exclusion criteria:
- history of cardiovascular disease
- type 2 diabetes
- orthopedic limitations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metabolically healthy obesity (MHO)
Healthy/normal metabolic profile
|
After baseline testing, participants followed a progressive resistance training program 3 times a week for 4 months.
|
Experimental: Metabolically unhealthy obesity (MUHO)
Abnormal metabolic profile
|
After baseline testing, participants followed a progressive resistance training program 3 times a week for 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin resistance (IR)
Time Frame: Baseline and after 4 months
|
Homeostasis Model Assessment (HOMA)-IR index = insulin (μUI/mL) x glucose (mmol/L)/22.5
|
Baseline and after 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antony Karelis, PhD, Université du Québec a Montréal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 9, 2011
Study Completion (Actual)
June 9, 2011
Study Registration Dates
First Submitted
September 12, 2023
First Submitted That Met QC Criteria
September 19, 2023
First Posted (Actual)
September 26, 2023
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQAM-SAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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