Primary outcomeMean· 16 weeks
Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI).
| Group | Value (fat/muscle ratio) | Spread |
|---|---|---|
| Dulagutide Arm | -0.009 | 0.0526 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataEffects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
Short name GLIMP
NCTNCT05254418 (opens ClinicalTrials.gov in a new tab)Other id220057
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 7 participants (actual)
- Sponsor
- Vanderbilt University Medical Center · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 15 Mar 2022
- Primary completion
- 1 May 2024
- Completion
- 1 Aug 2024
- First posted
- 24 Feb 2022
- Last update posted
- 20 Apr 2025
- Conditions
- Chronic Kidney Diseases
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2022202320242025
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- dulaglutide injectionDrug
Arms1
Experimental
dulagutide arm
Patient will receive 1.5 mg injections per week for 12 weeks.
Primary outcomes4
Outcomes the sponsor listed as primary.
Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI).
Time frame · 16 weeks
Registry description
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.
Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS).
Time frame · 16 weeks
Registry description
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.
Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test
Time frame · 16 weeks
Registry description
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)
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.
Time frame · 16 weeks
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcome· 16 weeks
Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS).
| Group | Value |
|---|---|
| Intervention | not posted |
Primary outcomeMean· 16 weeks
Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Dulagutide Arm | 0 | 2.24 |
Primary outcomeCount of participants· 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.
| Group | Value (Participants) |
|---|---|
| Dulagutide Arm | 2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Run-in-PeriodPatient will undergo a 4-week run in phase before starting the intervention. | 0 / 7 | 0 / 7 | 0 / 7 |
| Dulagutide ArmPatient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: The intervention will start at the beginning of the Treatment Phase and will continue for12 weeks of treatment. | 0 / 7 | 0 / 7 | 2 / 7 |
| Follow-upPatients will undergo a 4 week follow up phase after the intervention and before ending the study. | 0 / 7 | 0 / 7 | 0 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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