Investigation of glucagon-like peptide 2 (GLP-2) in dogs with chronic enteropathies

Purpose and Brief Study Description:

This study aims to compare blood levels of the gastrointestinal (GI) hormone GLP-2 in dogs with chronic GI disease to healthy dogs*. The study also evaluates the relationship between blood GLP-2 levels and fecal properties (bacterial populations and bile acids), as well as changes in blood levels of GLP-2 over time in dogs with chronic GI disease.

Prior to entry in this study, your dog must have a diagnosis of chronic GI disease, based on initial screening blood work, ≥4 weeks of clinical signs, and abdominal imaging (ultrasound).

If your dog takes part in the study, he/she will have blood drawn for measurement of red and white blood cell counts (CBC), serum chemistry panel (electrolytes and organ function) for inclusion, and fasted/post-eating GLP-2 levels. Urine concentration will be measured in some dogs to estimate dehydration. We will also collect fecal samples on the day of your dog’s appointment.

This study does not impact treatment for your dog’s GI disease, and your dog will receive standard-of-care therapy, as recommended by his/her primary veterinarian.

What does enrollment into this trial involve?

As a participant in this study, we will ask you not to feed your dog after 10:00 pm the night before his/her appointment, similar to a normal hospital appointment. Blood will be drawn and the samples submitted for initial screening blood work (CBC, chemistry panel) and fasted GLP-2 levels. If your dog’s creatinine (kidney value) is high, we will obtained a naturally voided urine sample to measure urine concentration and rule out kidney disease. Naturally-voided fecal samples will also be collected.

If your dog qualifies for the study based on screening blood work and abdominal imaging, he/she will be fed a small meal, consisting of a standard commercial diet, and a second blood draw will be performed 1 hour and 3 hours later for post-eating GLP-2 levels. Standard blood work (CBC, chemistry panel), fecal collection, and fasted/post-eating GLP-2 levels will be repeated in one month.

Study eligibility:

Inclusion criteria: Chronic primary GI disease: ≥4 weeks clinical signs, exclusion of other systemic disease based on CBC and serum chemistry panel, and abdominal ultrasound.

Exclusion criteria: <1 year of age, probiotic or steroid use within the previous month, evidence of systemic disease (e.g. renal disease, liver disease) on blood work or abdominal ultrasound, diagnosis of cancer or fungal disease, or unwillingness to eat the standard diet.

Client Compensation:

For enrolled dogs, the study will cover the recheck examination fee, CBC, and chemistry panel at the 30-day recheck. No direct compensation is provided and the owner is responsible for any additional testing, hospitalization or additional treatment, as recommended by the attending clinician.

Please note that some tests (fecal bacteria analysis, fecal bile acids, GLP-2) are performed at study completion and results will not be immediately available.

Owner Responsibilities:

Your dog will need to return to the KSU Veterinary Health Center 30 days after he/she was first admitted to the hospital for blood draw (CBC, chemistry panel, fasted/post-eating GLP-2) and fecal sample collection (bacterial populations, bile acids). We will also ask to you complete a survey about your dog’s clinical signs, stool quality, as well as his/her current diet and other medications at both the initial appointment and 30-day recheck. At the time of the recheck visit, we will ask you to collect a naturally-voided fecal sample at home and refrigerate overnight or collect a fresh sample on the morning of your dog’s appointment.

*Healthy dogs participating in this study :

As a healthy dog in this study, dogs will be fasted (no food after 10PM) the night before his/her appointment and baseline lab work (CBC, Chemistry Panel and fasted GLP-2 levels) will be performed. Urine will be collected in some dogs if needed to check kidney function. If your dog is determined to be healthy based on these screening tests, a post-eating blood sample for GLP-2 levels will be collected 1 hour and 3 hours after being fed a small meal, consisting of a standard commercial diet.

We will also ask you to bring a naturally-voided fecal sample collected at home either the night before your dog’s appointment and refrigerated overnight; or on the morning of your dog’s appointment and submitted within four hours of defecation. Fecal samples will be evaluated for bacterial populations and bile acids, if you dog is eligible for participation.

Inclusion criteria: Clinically healthy dog, >1 year of age, with no clinical signs of GI disease or therapeutic use of novel protein or hydrolyzed diet to control historical gastrointestinal signs, body condition score 4-6/9 (overall healthy weight).

Exclusion criteria: Historically documented chronic diseases/abnormalities on CBC/biochemistry panel, medications other than routine preventatives.

Fees for Services: No direct compensation is provided but laboratory tests and examination fee are performed at no cost to the owner.

Owner Responsibilities: Bring a naturally-voided fecal sample the day of your appointment, if possible. You will also fill out a questionnaire regarding your dog’s clinical signs, diet, and supplement history. No follow-up is required. Please note that some tests (fecal bacteria analysis, fecal bile acids, GLP-2) are performed at study completion and results will not be immediately available.

Contact Information:

Please contact Kris Richardson, Clinical Trials Coordinator at the Veterinary Health Center, for more information about this study. Phone: (785)-532-3046; email: ClinicalTrials@vet.k-state.edu