Potential reduction of systemic and pancreatic inflammation using fenofibrate in diabetic dogs

The University of Florida College of Veterinary Medicine is currently recruiting diabetic dogs for a clinical trial to evaluate the use of fenofibrate on markers of inflammation.

Enrollment Status: Closed

• Inclusion Criteria:
  1) Dogs (all breeds, neutered males and spayed females; body weight 5.0-45.0kg, ages 3-13 years) diagnosed with diabetes mellitus
  2) Treated with insulin (any type or dose) for at least 2 months,
  3) In good to moderate control defined by stable body weight and minimal increased drinking/urination
  4) Clients willing and able to use the flash glucose monitoring system (Freestyle Libre 2.0; clients will NOT be required to perform any blood draws at home for glucose measurements)
• Exclusion criteria:
  1) Diagnosis (or strong suspicion) of concurrent endocrine disease (hypercortisolism, hypothyroidism, other),
  2) Recent history (last 60 days) of diabetic ketoacidosis
  3) Treated with glucocorticoid medications (eye medications ok if continued throughout study)
  4) Received Cytopoint within 6 weeks of enrollment or Apoquel within 2 weeks.
  5) Other significant concurrent disease as assessed by the investigators
• Procedures/Treatment:
  1) A Freestyle Libre 2.0 sensor will be placed 7 days before the baseline visit, either during a visit to the UF Small Animal Hospital, by the owner, or by the referring veterinarian. Owners must scan the sensor approximately every 8 hours at minimum.
  2) A baseline visit (day 0) consists of a visit to the UF Small Animal Hospital, blood collection for baseline bloodwork and study sample banking. Fenofibrate will be prescribed and owners will give once daily by mouth for 21 days.
  3) Day 14: The Freestyle Libre 2.0 sensor will be replaced, either during a visit to the UF Small Animal Hospital, by the owner, or by the referring veterinarian. Owners must continue to scan the sensor approximately every 8 hours at minimum.
  4) Final visit (day 21) will occur at the UF Small Animal Hospital and will be the same as baseline visit, except that fenofibrate will be discontinued. The sensor may be removed any time after this visit.
• Costs: The study will cover the cost of the Freestyle Libre 2.0 sensors, everything included in the Baseline and Follow Up (Day 21) visits, and the fenofibrate tablets. If you do not have a Freestyle Libre 2.0 reader already, we will provide you with this as well.
• Contact: Please complete the Study Interest Form to see if your dog qualifies.
• Study Investigators: Dr. Chen Gilor and Dr. Allison O’Kell

Background:

Dogs with diabetes mellitus are predisposed to complications that occur throughout the body. These may include systemic (whole body) inflammation, high fat in the blood (hyperlipidemia), and inflammation of the pancreas (pancreatitis). Studies suggest that some of this inflammation may be caused by leakiness in the cells of the gut (gut barrier dysfunction).

Fenofibrate (TricorÔ) is a medication commonly used to treat hyperlipidemia in humans and dogs. This medication also has additional effects that may help treat gut barrier dysfunction and decrease inflammation in the pancreas. Fenofibrate is used in veterinary clinics to treat hyperlipidemia in dogs with and without diabetes, and is well tolerated with no reported side effects.

The purpose of this study is to determine if fenofibrate will decrease blood markers of systemic and pancreatic inflammation in dogs with diabetes, and to measure the effects on blood lipids and blood glucose control.

Funding for the research is provided through the efforts and generosity of the AKC Canine Health Foundation.