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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Christian Roberts, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01755962
First received: October 11, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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 Intervention
160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity
Other: Glycemic Load
Other: Resistance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Endothelial function as determined by brachial artery FMD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • monocyte inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insulin Sensitivity by Oral Glucose Tolerance Test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • MAGE via Continuous Glucose Monitoring System [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • body composition (total fat mass, visceral fat, HFF, LBM) via DXA and MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • plasma and cellular biomarkers post pre and post 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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


  • RNA/protein levels via muscle and fat tissue collection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755962

Contacts
Contact: Kevin Nizi, B.Kin, CSCS 310-825-8499 info@uclaemdr.com

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Christian K Roberts, PhD         
Sponsors and Collaborators
University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Christian Roberts, PhD, Assistant Research Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01755962     History of Changes
Other Study ID Numbers: 546464
Study First Received: October 11, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

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:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014