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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
Sponsor:
Information provided by (Responsible Party):
Scott M. Chadderdon, Oregon Health and Science University

Brief Summary:
The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.

Condition or disease Intervention/treatment Phase
Obesity Prediabetic State Sedentary Lifestyle Behavioral: High Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ages 30-60 years of age
  2. Overweight and Obese (28< BMI <45)
  3. Confirmed pre-diabetic (5.7≤ HbA1c < 6.5)
  4. Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7

Exclusion Criteria:

  1. Stage 3 chronic kidney disease (glomerular filtration rate [GFR] < 60)
  2. Obstructive Coronary artery disease
  3. Congestive heart failure (ejection fraction < 55%)
  4. Peripheral vascular disease,
  5. Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
  6. Know hypersensitivity to Definity® ultrasound contrast agent
  7. Intra-cardiac or pulmonary shunt
  8. The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement
  9. Physical activity greater than three hours per week
  10. Pregnancy

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): NCT02060240


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Scott M Chadderdon, MD Oregon Health and Science University

Publications:
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Responsible Party: Scott M. Chadderdon, Assistant Professor Cardiovascular Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02060240     History of Changes
Other Study ID Numbers: OHSUIRB#10299
5KL2TR000152-08 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

Keywords provided by Scott M. Chadderdon, Oregon Health and Science University:
Obesity
Prediabetic State
Sedentary Lifestyle
Insulin Resistance
Endothelium
Eicosanoids
Nitric Oxide
Regional Blood Flow

Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Prediabetic State
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents