Status:
COMPLETED
Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
VA Tennessee Valley Health Care System
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 out...
Eligibility Criteria
Inclusion
- Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)
- Age ≥ 18 years and ≤75 years
Exclusion
- Patients with type 1 diabetes mellitus
- 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
- BMI \<25 kg/m2, BMI \>40 kg/m2
- 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
- Uncontrolled hypertension (\>200/100 mmHg) despite optimal antihypertensive therapy
- Arrythmia, heart failure (NYHA class III-IV), valve disease or heart diseases other than coronary artery disease
- History of major gastrointestinal surgery, inflammatory bowel disease, pancreatitis or cholelithiasis
- Personal or family history of medullary thyroid cancer, or personal history of Multiple Endocrine Neoplasia (MEN)-2
- Pregnancy, breast feeding or intention to become pregnant
- Previous renal transplantation
- Acute or chronic infectious diseases
- Cancer or chemotherapy within 3 years prior to study
- Treatment with systemic corticosteroids within 3 months prior to study
- Known or suspected allergy to dulaglutide
- Claustrophobia or other contraindications for magnetic resonance imaging
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05254418
Start Date
March 15 2022
End Date
August 1 2024
Last Update
April 20 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232