Clinical Trial: Effects of an Immunosuppressant Mycophenolate Mofetil or MMF on the Urinary Sodium Excretion Response to Mental Stress

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparing the Effects of an Immunosuppressant (Mycophenolate Mofetil or MMF) on the Urinary Sodium Excretion Response to Mental Stress in a Crossover Design (MMF)

Brief Summary: The purpose of this study is to determine if stopping the stress induced increase in inflammation will prevent sodium retention which in turn increases blood pressure. Each subject will test two separate times. One week, they will be taking a daily dose of mycophenolate mofetil (MMF), the other week they will be taking a placebo.

Detailed Summary:

This study will involve a screening visit and two testing weeks over an approximate 3 week period (this includes a one week "washout" period).

Each testing week will have a 3 day salt-controlled diet prior to testing and an approximate 3-hour testing period on Day 4. The 3-hour testing period will include 10 minutes of a baseline rest, 45 minutes of mild stress (competitive video game), and 45 minutes of a recovery rest. A total of 4 blood and 4 urine samples will be collected during the 3-hour period. Each blood draw will consist of about 7 teaspoons for a total of 28 teaspoons per testing week.

During the screening and testing, I will be asked to take the MoCA (the Montreal Cognitive Assessment) test in order to measure cognitive thinking after stress. It is a brief 30-question test which takes around 10 minutes to complete. It measures different types of cognitive abilities, including orientation (the approximate position of something/someone), short-term memory (remember information for a short period of time), executive function (planning and problem solving), language abilities (assign appropriate names to appropriate items), and visuospatial ability (determine distance from one object to another). Each question is awarded a particular number of points depending on the accuracy of the answers given. We will be looking to see if the total number of points earned changes in response before and after stress.

Screening Visit: I will come to the GPI or the CRU for a screening visit that will last about 90 minutes. The study will be described in detail and an informed consent will be obtained. Vital signs will be taken (blood pressure, height, weight and BMI - Body Mass Index. A health history and a limited physical exam will be conducted by Dr. White (or a physic
Sponsor: Augusta University

Current Primary Outcome: Urinary sodium excretion rate [ Time Frame: 2 hours ]

primary variable of interest is the difference in stress induced changes in sodium excretion between placebo and treatment conditions.


Original Primary Outcome: Same as current

Current Secondary Outcome: Hemodynamics- change in systolic blood pressure compared to changes in sodium excretion [ Time Frame: 2 hours ]

measures of change in systolic blood pressure compared to changes in sodium excretion in treatment verses placebo.


Original Secondary Outcome: Same as current

Information By: Augusta University

Dates:
Date Received: April 17, 2015
Date Started: April 2014
Date Completion: April 2020
Last Updated: December 7, 2016
Last Verified: December 2016