Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
GET FIT
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2017
CompletedNovember 16, 2020
November 1, 2020
5.7 years
October 11, 2012
November 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial function as determined by brachial artery FMD
12 weeks
Secondary Outcomes (3)
monocyte inflammation
12 weeks
Insulin Sensitivity by Oral Glucose Tolerance Test
12 weeks
MAGE via Continuous Glucose Monitoring System
12 weeks
Other Outcomes (3)
body composition (total fat mass, visceral fat, HFF, LBM) via DXA and MRI
12 weeks
plasma and cellular biomarkers post pre and post 12 week intervention
12 weeks
RNA/protein levels via muscle and fat tissue collection
12 weeks
Study Arms (4)
Low Glycemic Load + Resistance Training
EXPERIMENTAL12-week intervention diet + resistance training (1 hour, 3 times per week)
High Glycemic Load + Resistance Training
EXPERIMENTAL12-week control diet + resistance training (1 hour, 3 times per week)
Low Glycemic Load
EXPERIMENTAL12-week intervention diet
High Glycemic Load
OTHER12-week control diet
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Carpenter, PhD, MPH
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2012
First Posted
December 24, 2012
Study Start
April 1, 2012
Primary Completion
December 14, 2017
Study Completion
December 14, 2017
Last Updated
November 16, 2020
Record last verified: 2020-11