Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
- Status
- CompletedResults posted
- Why it is watched
- non-weight indication: kidney, muscle
- Who it enrolls
- age 18 Years to 75 Years; excludes diabetes; no BMI minimum stated; conditions: Chronic Kidney Diseases
- Interventions
- dulaglutide injection
- Conditions
- Chronic Kidney Diseases
- Phase and size
- Phase 2 · 7 participants
- Dates
- Start 2022-03-15
Primary completion 2024-05-01 - Sponsor
- Vanderbilt University Medical Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI).16 weeks
- Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS).16 weeks
- Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test16 weeks
- Safety and Feasibility of Dulaglutide Treatment as Evaluated by Subject Interview, Continuous Glucose Monitoring, Adverse Events (AE), Laboratory Tests, Vital Signs, ECG & Allergic/Hypersensitivity Reactions.16 weeks
02Eligibility
Who can take part
Inclusion Criteria: 1. Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2) 2. Age ≥ 18 years and ≤75 years Exclusion Criteria: 1. 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
03Change log
Registry changes
No changes recorded since the trial was added.