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Resistance Training and Cardiometabolic Risk

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
Université du Québec a Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    September 12, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Université du Québec a Montréal
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    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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