NCT05254418CompletedPhase 2
Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
Effects of Glucagon-Like Peptide-1 Agonists on Metabolism and Ectopic Fat Deposition in Chronic Kidney Disease: A Pilot and Feasibility Study
Source: ClinicalTrials.gov · Last updated 20 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 1 Feb 2022
- Start date
- 15 Mar 2022
- Primary completion date
- 1 May 2024
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT05254418
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 7
- From 15 Mar 2022 to the primary completion date, 1 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous renal transplantation
- Cancer or chemotherapy within 3 years prior to study
- Treatment with systemic corticosteroids within 3 months prior to study
Other illness
- Patients with type 1 diabetes mellitus
- 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
- Acute or chronic infectious diseases
- Known or suspected allergy to dulaglutide
Lab values
- 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
Other
- BMI \<25 kg/m2, BMI \>40 kg/m2
- Pregnancy, breast feeding or intention to become pregnant
- Claustrophobia or other contraindications for magnetic resonance imaging
Who the study is looking for
- Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)
- Age ≥ 18 years and ≤75 years
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.