Primary outcome
What GLIMP measured first
| Dulagutide Armn=7 |
|---|
| -0.009(0.0526) |
| Dulagutide Armn=7 |
|---|
| 0(2.24) |
| Dulagutide Armn=7 |
|---|
| 2 |
Phase 2 · Dulaglutide
GLIMP trial results
Effects of Glucagon-Like Peptide-1 Agonists on Metabolism and Ectopic Fat Deposition in Chronic Kidney Disease: A Pilot and Feasibility Study
- Participants
- 7
- Status
- completed
- Completed
- 2024-08-01
- Sponsor
- Vanderbilt University Medical Center
As posted on ClinicalTrials.gov (NCT05254418), updated at source Apr 20, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in GLIMP
Percent of participants affected, 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.. The most common events the registry lists.
| Event | Run-in-Period | Dulagutide Arm | Follow-up |
|---|---|---|---|
| Any serious event | 0% | 0% | 0% |
| nausea | not reported | 14.3% | not reported |
| local injection site erythema | not reported | 14.3% | not reported |
The trial
How GLIMP was run
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.
- dulagutide arm: Patient will receive 1.5 mg injections per week for 12 weeks.
Who could join the trial
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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