Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

Study Overview
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Brief Summary
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This project is prompted by the urgent public health need to identify novel strategies to prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative.

Detailed Description
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At present, the extent to which dietary components can modify endothelial function, monocyte inflammation and glycemic variations is not well defined, although different carbohydrates are known to vary in their abilities to induce plasma glucose and insulin responses. Epidemiologic work suggests that high dietary glycemic load (GL) is associated with increased concentrations of inflammatory cytokines, endothelial dysfunction markers, and increased risk of T2D and coronary heart disease (CHD). We are examining using randomized control trials low vs. high-GL diet to determine if low-GL diets induce improvements in endothelial function or monocyte inflammation. Furthermore, resistance training is an alternate form of exercise from conventional aerobic training. Resistance Training has the potential to improve endothelial function or monocyte phenotype, but there is very little data in this area. We hypothesize that resistance training may augment the beneficial effects of a low-GL diet in improving metabolic health.

Official Title
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Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

Conditions
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160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity

Intervention / Treatment
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* Other: Glycemic Load
* Other: Resistance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-35 with BMI≥30 and/or your waist circumference ≥40 inches for males or ≥35 inches for females In good health as determined by the screening visit and review of medical history Exclusion Criteria: Have a known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading or use of medications that influence CV function Have been in a weight loss or exercise program in the 6 months prior to participation Use tobacco products Have a syndrome or are prescribed medications that may influence body composition, insulin action, or CVD (e.g. PCOS, prednisone, methylphenidate, etc.) Have intolerance to lactose or gluten Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: There are four intervention arms designed to compare two factors, glycemic load and resistance training. Arms consist of high glycemic diet, no exercise, high glycemic diet, resistance training; low glycemic diet, no exercise; low glycemic diet, resistance training.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Glycemic Load + Resistance Training<br>12-week intervention diet + resistance training (1 hour, 3 times per week) | Other: Glycemic Load<br> <br> Other: Resistance Training<br> <br> |
| Experimental: High Glycemic Load + Resistance Training<br>12-week control diet + resistance training (1 hour, 3 times per week) | Other: Glycemic Load<br> <br> Other: Resistance Training<br> <br> |
| Experimental: Low Glycemic Load<br>12-week intervention diet | Other: Glycemic Load<br> <br> |
| Other: High Glycemic Load<br>12-week control diet | Other: Glycemic Load<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function as determined by brachial artery FMD |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monocyte inflammation |  | 12 weeks | 
| Insulin Sensitivity by Oral Glucose Tolerance Test |  | 12 weeks | 
| MAGE via Continuous Glucose Monitoring System |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, obese, overweight, exercise, resistance training, nutrition, glycemic load, body composition, weight training, lifestyle