Phase 2
Completed N=7
Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
Chronic Kidney Diseases
Source: ClinicalTrials.gov NCT05254418 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI). — -0.009 fat/muscle ratio
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI). |
-0.009 | — |
| PRIMARY Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS). |
— | — |
| PRIMARY Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test |
— | — |
| PRIMARY 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. |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)
- Age ≥ 18 years and ≤75 years
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT05254418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.