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Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01755962
Acronym
GET FIT
Enrollment
88
Registered
2012-12-24
Start date
2012-04-30
Completion date
2017-12-14
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERResistance Training

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Endothelial function as determined by brachial artery FMD12 weeks

Secondary

MeasureTime frame
monocyte inflammation12 weeks
Insulin Sensitivity by Oral Glucose Tolerance Test12 weeks
MAGE via Continuous Glucose Monitoring System12 weeks

Other

MeasureTime frameDescription
plasma and cellular biomarkers post pre and post 12 week intervention12 weeksMonocytes will be isolated from subject whole blood and will be phenotyped in 2 ways: 1) as pro- or anti-inflammatory based on flow-activated cell sorting (FACS) analysis of monocyte-specific markers TLR-4, CD14 and CD16. Serum-Stimulated Cell Culture. Subject serum will be incubated with L6 cells as we have previously performed in monocytes and adipocytes as well as endothelial cells 18, 130. Following 48 hr incubation, cellular insulin-stimulated glucose transport will be assayed as described 129 and conditioned medium assayed for myokine levels (ex. IL-15, 1L-6, etc). Fasting plasma (and conditioned media where appropriate) will be taken to determine a panel of adipokines and hormones (e.g. insulin, adiponectin, HSP-72, IL-4, IL-6, IL-10, MCP-1, CRP, 8-iso PGF2α) will be measured using the Millipore Multiplex assay kit or with specific ELISA kits
RNA/protein levels via muscle and fat tissue collection12 weeksApproximately 300 mg of muscle tissue from the superficial portion of the vastus lateralis and approximately 3-5 g of subcutaneous adipose tissue from the periumbilical portion of the abdomen will be obtained.
body composition (total fat mass, visceral fat, HFF, LBM) via DXA and MRI12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026