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Peripheral Vasodilation in Obese Humans (ObeseDilate)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833207
First Posted: July 14, 2016
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
The growing population of obese adults is predicted to create a large public health burden in the next few decades. This study examines function of small blood vessels providing blood flow to skeletal muscles, to test if younger obese individuals (<40 years old, BMI >30) are already displaying reductions in blood vessel function. This study will test if the signals blood vessels use to increase blood flow are changing in these same subjects. Findings from this study may help create treatments to delay or prevent some of the negative effects of obesity on vascular health.

Condition Intervention Phase
Obesity Drug: Drug Trial 1 (EDD) Drug: Drug Trial 2 (ROV) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Peripheral Vasodilation in Obese Humans

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in limb blood flow in response to stimuli that cause vasodilation (ATP, ISO, BK, Ach, muscle contractions). [ Time Frame: Through study completion ]
    Change in limb blood flow (ml/min), measured with Doppler ultrasound, in response potassium vasodilation (EDD or ROV). The change in blood flow will be calculated by taking the difference between the stimulus blood flow response and the baseline blood flow. These changes will be compared between lean and obese.

  • Change in limb blood flow in response to barium chloride infusion which inhibits potassium channel vasodilation. [ Time Frame: Through study completion ]
    Change in limb blood flow (ml/min), measured with Doppler ultrasound, in response to barium chloride infusion (inhibition of K+ vasodilation). This will be calculated by taking the difference between the stimulus blood flow response and the stimulus blood flow response in the presence of barium chloride. These changes will be compared between lean and obese.


Secondary Outcome Measures:
  • Endothelial cell collection from arterial catheter to measure protein expression. [ Time Frame: Through study completion ]
    Protein expression in endothelial cells harvested from arterial catheter that may be responsible for EDD or ROV functional changes (optional for subjects). Immunohistochemical methods will be used. Differences in protein expression will be assessed semi-quantitatively by normalizing expression to standard human endothelial cell cultures.

  • Change in blood flow in response of L-NMMA and ketorolac in the presence of barium chloride [ Time Frame: Minutes/seconds between baseline and peak response to stimuli ]
    Change in limb blood flow (ml/min), measured with Doppler ultrasound, in response to L-NMMA and ketorolac infusion in the presence of barium chloride infusion. This will be calculated by taking the difference between the stimulus blood flow response and the stimulus blood flow response in the presence of all inhibitors (barium chloride, ketorolac, and L-NMAA). These changes will be compared between lean and obese.


Estimated Enrollment: 360
Study Start Date: July 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EDD Obese
On study visit after screening. Brachial artery catheter in the non-dominant arm + infusion drugs (IND approval) to test basic vascular function and associated mechanisms in healthy volunteers. Eligible obese subjects will undergo Drug Trial 1 (EDD) (described in Intervention section).
Drug: Drug Trial 1 (EDD)

Drugs that increase blood flow and test EDD are: ACh, ISO, BK, ATP. Remaining drugs used to test mechanisms of EDD: L-NMMA, ketorolac, and BaCl2.

Details under study description.

Other Name: EDD
Experimental: EDD Lean
On study visit after screening. Brachial artery catheter in the non-dominant arm + infusion drugs (IND approval) to test basic vascular function and associated mechanisms in healthy volunteers. Eligible lean subjects will undergo Drug Trial 1 (EDD) (described in Intervention section).
Drug: Drug Trial 1 (EDD)

Drugs that increase blood flow and test EDD are: ACh, ISO, BK, ATP. Remaining drugs used to test mechanisms of EDD: L-NMMA, ketorolac, and BaCl2.

Details under study description.

Other Name: EDD
Experimental: ROV Obese
On study visit after screening. Brachial artery catheter in the non-dominant arm + infusion drugs (IND approval) to test basic vascular function and associated mechanisms in healthy volunteers. Eligible obese subjects will undergo Drug Trial 2 (ROV) (described in Intervention section).
Drug: Drug Trial 2 (ROV)

Tools used to increase blood flow: muscle contractions and ATP. Remaining drugs used to test mechanisms of ROV: L-NMMA, ketorolac, and BaCl2.

Details under study description.

Other Name: ROV
Experimental: ROV Lean
On study visit after screening. Brachial artery catheter in the non-dominant arm + infusion drugs (IND approval) to test basic vascular function and associated mechanisms in healthy volunteers. Eligible lean subjects will undergo Drug Trial 2 (ROV) (described in Intervention section).
Drug: Drug Trial 2 (ROV)

Tools used to increase blood flow: muscle contractions and ATP. Remaining drugs used to test mechanisms of ROV: L-NMMA, ketorolac, and BaCl2.

Details under study description.

Other Name: ROV

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overnight fast
  • No exercise, caffeine, or NSAIDS for a minimum of 24 hours
  • Fasting blood glucose <100 mg/dL
  • Fasting blood cholesterol <200 mg/dL
  • Fasting blood triglycerides <150
  • Blood pressure < 120/80 mmHg(Lean control) and <140/90 mmHg (Obese subjects)

Exclusion Criteria:

  • Increased risk of bleeding, sensitivity to lidocaine, procoagulant disorders and other clotting disorders,
  • History of cardiovascular, liver, or kidney disease,
  • Cardiovascular medications,
  • Smoking history,
  • Vigorous exercise >60 minutes per week,
  • Obstructive sleep apnea, metabolic syndrome, or diabetes,
  • Hypertension,
  • Regular use of Aspirin or NSAIDS ((≥5 days/wk),
  • Women: breastfeeding, pregnant, or premenopausal.
  Contacts and Locations
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): NCT02833207


Locations
United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: William Schrage, Ph.D. UW Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02833207     History of Changes
Other Study ID Numbers: 2011-0199
First Submitted: July 12, 2016
First Posted: July 14, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Wisconsin, Madison:
blood flow
vasodilation
skeletal muscle
Doppler Ultrasound
diabetes prevention program
endothelium dependent dilation