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Study 3: Minocycline Decreases Microglia Activation

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ClinicalTrials.gov Identifier: NCT02213575
Recruitment Status : Recruiting
First Posted : August 11, 2014
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study is a mechanistic study that will enroll 9 subjects who are participating in NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in PET and MRI imaging.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Minocycline Phase 1

Detailed Description:
This study will recruit 9 subjects from NCT02133885 who will agree to undergo additional autonomic testing and imaging studies at baseline and after 3-6 months of study treatment. Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in Montreal Canada.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Minocycline
Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.
Drug: Minocycline
Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.




Primary Outcome Measures :
  1. MRI changes in the paraventricular nucleus [ Time Frame: Change from baseline to 12 weeks ]
    MRI changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)

  2. MRI changes in the paraventricular nucleus [ Time Frame: Change in Baseline to 24 weeks ]
    MRI changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)

  3. PET changes in the paraventricular nucleus [ Time Frame: Change from baseline to 12 weeks ]
    PET changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)

  4. PET changes in the paraventricular nucleus [ Time Frame: Change in Baseline to 24 weeks ]
    PET changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects participating in IRB approved protocol #102-2013 will be eligible to participate.

Exclusion criteria for control and resistant hypertensive subjects include:

  • currently pregnant or have been pregnant in the last 6 months;
  • antibiotic treatment within 2 months of study enrollment;
  • currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
  • unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection);
  • history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.

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): NCT02213575


Contacts
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Contact: Dana Leach, DNP 352-273-8933 leachdd@medicine.ufl.edu
Contact: Sarah Long, RN 352-273-8933 sarah.long@medicine.ufl.edu

Locations
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United States, Florida
UF Health Cardiovascular Clinic Recruiting
Gainesville, Florida, United States, 32610
Contact: Dana Leach, DNP    352-273-8933    leachdd@medicine.ufl.edu   
Sponsors and Collaborators
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Carl Pepine, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02213575     History of Changes
Other Study ID Numbers: IRB201500594 -N
RO1HL3361028 ( Other Identifier: National Heart, Lung and Blood Institute (NHLBI) )
2013-00102 Study 3 ( Other Identifier: Univeristy of Florida )
R01HL13244801 ( Other Grant/Funding Number: National Institute of Health )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Florida:
Resistent Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents