Clinical trial NCT01755962: Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
Official title: Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity
Keywords: diet
obese
overweight
exercise
resistance training
nutrition
glycemic load
body composition
weight training
lifestyle
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial function as determined by brachial artery FMD
timeFrame: 12 weeks
Secondary outcomes:
measure: monocyte inflammation
timeFrame: 12 weeks
measure: Insulin Sensitivity by Oral Glucose Tolerance Test
timeFrame: 12 weeks
measure: MAGE via Continuous Glucose Monitoring System
timeFrame: 12 weeks
Other outcomes:
measure: body composition (total fat mass, visceral fat, HFF, LBM) via DXA and MRI
timeFrame: 12 weeks
measure: plasma and cellular biomarkers post pre and post 12 week intervention
timeFrame: 12 weeks
measure: RNA/protein levels via muscle and fat tissue collection
timeFrame: 12 weeks
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Catherine Carpenter, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: