Resistance Training and Cardiometabolic Risk
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Metabolically healthy obesity (MHO)
Metabolically unhealthy obesity (MUHO)
Arm Description
Healthy/normal metabolic profile
Abnormal metabolic profile
Outcomes
Primary Outcome Measures
Insulin resistance (IR)
Homeostasis Model Assessment (HOMA)-IR index = insulin (μUI/mL) x glucose (mmol/L)/22.5
Secondary Outcome Measures
Full Information
NCT ID
NCT06054594
First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
Université du Québec a Montréal
1. Study Identification
Unique Protocol Identification Number
NCT06054594
Brief Title
Resistance Training and Cardiometabolic Risk
Official Title
Resistance Training and Cardiometabolic Risk in Women With Metabolically Healthy and Unhealthy Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 9, 2011 (Actual)
Study Completion Date
June 9, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec a Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
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 ftiness 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metabolically healthy obesity (MHO)
Arm Type
Experimental
Arm Description
Healthy/normal metabolic profile
Arm Title
Metabolically unhealthy obesity (MUHO)
Arm Type
Experimental
Arm Description
Abnormal metabolic profile
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
After baseline testing, participants followed a progressive resistance training program 3 times a week for 4 months.
Primary Outcome Measure Information:
Title
Insulin resistance (IR)
Description
Homeostasis Model Assessment (HOMA)-IR index = insulin (μUI/mL) x glucose (mmol/L)/22.5
Time Frame
Baseline and after 4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antony Karelis, PhD
Organizational Affiliation
Université du Québec a Montréal
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Resistance Training and Cardiometabolic Risk
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