Multiple Risk Factor Intervention Trial (Ms. FIT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Disturbance
- Sponsor
- University of Toronto
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Insulin resistance
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:
- How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?
- What is the effect modification of adding a diet quality intervention to exercise?
- What is the effect modification by menopausal status?
The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause.
Investigators
Amy Kirkham
Assistant Professor
University of Toronto
Eligibility Criteria
Inclusion Criteria
- •Biologically female
- •Pre- or postmenopausal: Premenopause: having regular menstrual cycles (21-35 days long without a persistent difference of ≥7 days between cycles). Post-menopause: ≥12 months of amenorrhea or history of double oophorectomy and do not have irregular or occasional menstrual cycle in last 12 months.
- •Participants will have multiple risk factors for cardiometabolic disease, namely: being sedentary (\<30 min of moderate-vigorous physical activity/week), having a BMI ≥ 25 kg/m\^2, and one or more of the following: a waist circumference indicative of abdominal obesity, specific to BMI (e.g., BMI 25-29.9: WC: ≥90cm; BMI 30-34.9: WC: ≥105cm; BMI 35-35.9: WC: ≥115cm) OR a diagnosis of either hypertension, pre-diabetes (heightened blood sugar levels), or dyslipidemia (heightened blood lipid levels)
- •Able to commit to come to the University once per week for 24 weeks.
Exclusion Criteria
- •Perimenopausal or those whom the investigators cannot discern pre- vs perimenopausal status
- •Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (e.g., Chronic obstructive pulmonary disease (COPD) or severe or uncontrolled asthma).
- •Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.)
- •American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and/or endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \>200mmHg/100mmHg, a cancer diagnosis other than skin cancer)
- •Unable to provide informed consent or communicate in English
- •Pregnant or breast-feeding currently or in the past 3 months
- •Mobility limitations to aerobic exercise (i.e., wheelchair, walker use, limp impeding walking)
- •Smoking cigarettes or marijuana within the past 3 months
- •Taking exogenous hormones in any format currently or in the past 3 months
- •Contraindications to research MRI (e.g., pacemaker, magnetic implants)
Outcomes
Primary Outcomes
Insulin resistance
Time Frame: 6 months
As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).
Secondary Outcomes
- Hepatic insulin resistance(6 months)
- Metabolic syndrome severity(6 months)
- Framingham 10-year risk (%)(6 months)