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

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 is a drug known to decrease blood lipid levels that has also shown promise in laboratory settings to decrease other consequences of DM such as gut barrier dysfunction, systemic inflammation and pancreatitis. Investigators hypothesize that fenofibrate treatment in spontaneous canine DM will reduce systemic inflammation and decrease serum pancreatic lipase activity (a marker of pancreatic inflammation), and positively alter lipoprotein profiles without affecting blood sugar (glycemic) control.

The results of this study will be used to design a larger long-term longitudinal clinical trial which will evaluate risk-reduction of pancreatitis and other DM complications by fenofibrate in dogs.

Participation Requirements:

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

Owner's Responsibilites:

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 be given 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.