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OpenTrials
Completed

NCT Number: NCT01755962

Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glycemic Load

Other

Resistance training

Other

Primary outcomes

  1. Endothelial function as determined by brachial artery FMD

    Time frame: 12 weeks

Secondary outcomes

  1. monocyte inflammation

    Time frame: 12 weeks

  2. Insulin Sensitivity by Oral Glucose Tolerance Test

    Time frame: 12 weeks

  3. MAGE via Continuous Glucose Monitoring System

    Time frame: 12 weeks

Other outcomes

  1. body composition (total fat mass, visceral fat, HFF, LBM) via DXA and MRI

    Time frame: 12 weeks

  2. plasma and cellular biomarkers post pre and post 12 week intervention

    Time frame: 12 weeks

    Monocytes 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

  3. RNA/protein levels via muscle and fat tissue collection

    Time frame: 12 weeks

    Approximately 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: GET FIT

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2012
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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