Vanderbilt Clinical Trials

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Purpose

Chronic kidney disease (CKD) is a burden of morbidity and mortality. Increased protein breakdown in skeletal muscle (wasting) and ectopic fat deposition are important determinants of poor clinical outcome in patient with CKD. Insulin resistance plays a critical role in skeletal muscle wasting and ectopic fat deposition. Glucagon-like peptide-1 receptor agonists (GLP-1RA) decrease ectopic fat deposition in patients with type 2 diabetes, prediabetes, obese and overweight subjects. The influence of GLP-1RA on ectopic fat deposition in CKD patients in unknown. The investigators' will test the hypothesis that GLP-1RA decreases intermuscular (ectopic) fat deposition in patients with stage 3-4 CKD. The investigators' will do so by addressing the following specific aims: Specific Aim 1: To test the hypothesis that GLP-1RA decreases intermuscular fat deposition in patients with stage 3-4 CKD. Specific Aim 2: To test the hypothesis that GLP-1RA improves skeletal muscle mitochondrial function in patients with stage 3-4 CKD. Specific Aim 3: To test the hypothesis that GLP-1RA improves physical performance in patients with stage 3-4 CKD. Specific Aim 4: To test the safety and feasibility of 12 weeks of dulaglutide 1.5 mg/wk administration as an adjunct therapy to the standard care of patients with stage 3-4 CKD.

Condition

Chronic Kidney Diseases

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2) 2. Age ≥ 18 years and ≤75 years

Exclusion Criteria

Patients with type 1 diabetes mellitus 2. Patients with T2D who are on insulin therapy or who started a new antidiabetic medication within 1 month prior to study or who received incretin-based therapy within 3 months prior to study 3. BMI <25 kg/m2, BMI >40 kg/m2 4. HbA1c>8% measured within 1 month prior to study, or a history of hypoglycemic episode within 1 year prior to study, or a history of diabetic ketoacidosis 5. Uncontrolled hypertension (>200/100 mmHg) despite optimal antihypertensive therapy 6. Arrythmia, heart failure (NYHA class III-IV), valve disease or heart diseases other than coronary artery disease 7. History of major gastrointestinal surgery, inflammatory bowel disease, pancreatitis or cholelithiasis 8. Personal or family history of medullary thyroid cancer, or personal history of Multiple Endocrine Neoplasia (MEN)-2 9. Pregnancy, breast feeding or intention to become pregnant 10. Previous renal transplantation 11. Acute or chronic infectious diseases 12. Cancer or chemotherapy within 3 years prior to study 13. Treatment with systemic corticosteroids within 3 months prior to study 14. Known or suspected allergy to dulaglutide 15. Claustrophobia or other contraindications for magnetic resonance imaging

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Sequential Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental dulagutide arm	Patient will receive 1.5 mg injections per week for 12 weeks.	Drug: dulaglutide injection All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication

More Details

Status: Completed
Sponsor: Vanderbilt University Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.