Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0023
Source ID: NCT05254418
Associated Drug: Dulaglutide Injection
Title: Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
Acronym: GLIMP
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05254418/results
Conditions: Chronic Kidney Diseases
Interventions: DRUG: dulaglutide injection
Outcome Measures: Primary: Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI)., Sequential MRI will be performed during the run-in phase, at the beginning and end of the dulaglutide treatment and at the end of the observational follow up period. Intermuscular fat will be calculated as the ratio between intermuscular fat and muscle volumes in the mid-thigh region. Changes in intermuscular fat deposition will be calculated. the reported value is the difference between the end of study and baseline values (end of study minus baseline). A negative value will reflect a decrease in IMAT., 16 weeks|Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS)., Sequential 31P-MRS, a gold standard technique for muscle mitochondrial function assessment, will be performed during the run-in phase, at the beginning and end of the dulaglutide treatment and at the end of the observational follow up period. Changes in phosphocreatine recovery time constant will be assessed., 16 weeks|Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test, Systemic physical performance battery test will be performed at the beginning and end of the dulaglutide treatment period. Changes will be assessed. The total score that will be reported is calculated by adding scores obtained from Balance test, Gait speed test and Chair stand test scores. The score for the primary outcome will be the difference between baseline and end of study. The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three or four classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance); or four classes: 0-3 points (disability/very poor performance), 4-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance), 16 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., An AE will be defined as any undesirable medical event occurring to a subject in a clinical trial, whether it is related to the study agent. All adverse events will be graded as follows: 0 = No adverse events or within normal limits; 1 = Mild-did not require treatment; 2 = Moderate resolved with treatment; 3 = Severe-required professional medical attention; 4 = Life-threatening or disabling; 5 = Death., 16 weeks |
Sponsor/Collaborators: Sponsor: Vanderbilt University Medical Center | Collaborators: VA Tennessee Valley Health Care System
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 7
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-03-15
Completion Date: 2024-08-01
Results First Posted: 2025-04-20
Last Update Posted: 2025-04-20
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
URL: https://clinicaltrials.gov/show/NCT05254418