Physical Activity and Obesity
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|ClinicalTrials.gov Identifier: NCT02060240|
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Prediabetic State Sedentary Lifestyle||Behavioral: High Activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physical Activity and Obesity: The Role of Nitric Oxide and Eicosanoids in Regulating Capillary Perfusion and Vascular Insulin Resistance|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2017|
Experimental: High Activity Group
Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.
Behavioral: High Activity
The high activity group will undergo a 12 week ramped exercise protocol.
No Intervention: Standard of Care Group
The standard of care group will maintain their baseline level of activity for 12 weeks
- Insulin mediated skeletal muslce blood flow and capillary recruitment [ Time Frame: 3 months ]Contrast enhanced ultrasound skeltal muscle perfusion imaging will be performed at rest and during glucose steady state infusion during an insulin clamp. The change in blood flow will be determined between the resting state and at peak steady state to determine the absolute increase in skeletal muslce blood flow (ml/min/g) as well as the absolute increase in capillary blood volume (ml/g) of tissue
- Quantification of endothelial derived Vasodilators [ Time Frame: 3 months ]To quantify the changes in endothelial derived vasodilators. For this aim nitric oxide bioavailability as tested by flow mediated vasodilation will be performed and reported as absolute change (cm) and percent change (%) in brachial artery diameter from baseline to post ischemic occlusion of the forearm. Plasma samples for eicosanoids will be collected and assessed by liquid chormatography/mass spectroscopy to to assess changes in endothelial derived vasodilators.
- Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity [ Time Frame: 3 months ]Aim 3. To correlate changes in fitness as measured by peak VO2 and anaerobic threshold during cardiopulmonary exercise testing with changes in endothelial derived vasodilators, skeletal muscle blood flow, and insulin sensitivity.
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): NCT02060240
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Scott M Chadderdon, MD||Oregon Health and Science University|