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Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity (GET FIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755962
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity Other: Glycemic Load Other: Resistance Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
Study Start Date : April 2012
Actual Primary Completion Date : December 14, 2017
Actual Study Completion Date : December 14, 2017

Arm Intervention/treatment
Experimental: Low Glycemic Load + Resistance Training
12-week intervention diet + resistance training (1 hour, 3 times per week)
Other: Glycemic Load
Other: Resistance Training
Experimental: High Glycemic Load + Resistance Training
12-week control diet + resistance training (1 hour, 3 times per week)
Other: Glycemic Load
Other: Resistance Training
Experimental: Low Glycemic Load
12-week intervention diet
Other: Glycemic Load
High Glycemic Load
12-week control diet
Other: Glycemic Load



Primary Outcome Measures :
  1. Endothelial function as determined by brachial artery FMD [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755962


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Catherine Carpenter, PhD, MPH University of California, Los Angeles
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01755962    
Other Study ID Numbers: 546464
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Keywords provided by University of California, Los Angeles:
diet
obese
overweight
exercise
resistance training
nutrition
glycemic load
body composition
weight training
lifestyle
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases