Clinical trial NCT02213575: Study 3: Minocycline Decreases Microglia Activation
Official title: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hypertension
Keywords: Resistent Hypertension
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-08-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Subjects participating in IRB approved protocol #102-2013 will be eligible to participate.
* (For Study 3 Participants only) Willing to travel to Montreal, Canada for specialized imaging of the participant's brain using magnetic resonance imaging (MRI), positron emission tomography (PET) scanning, Autonomic Nervous System Testing and blood drawing- if participant qualifies

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.

Primary outcomes:
measure: MRI changes in the paraventricular nucleus
timeFrame: Change from baseline to 12 weeks
measure: MRI changes in the paraventricular nucleus
timeFrame: Change in Baseline to 24 weeks
measure: PET changes in the paraventricular nucleus
timeFrame: Change from baseline to 12 weeks
measure: PET changes in the paraventricular nucleus
timeFrame: Change in Baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cardiovascular Clinic
state: Florida
Study officials:
affiliation: University of Florida
name: Carl Pepine, MD
role: PRINCIPAL_INVESTIGATOR
References: