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Dulaglutide for Chronic Kidney Disease (GLIMP Trial)
Phase 2
Recruiting
Led By Alp Ikizler, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)
Age ≥ 18 years and ≤75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
GLIMP Trial Summary
This trial will study whether a drug called a GLP-1RA can help decrease fat deposition and improve physical performance in patients with stage 3-4 CKD.
Who is the study for?
This trial is for adults aged 18-75 with stage 3-4 chronic kidney disease (CKD), not on insulin or new diabetes meds in the last month, and without a history of certain cancers, major GI surgery, pancreatitis, severe heart conditions, uncontrolled high blood pressure, recent steroid treatment or infectious diseases.Check my eligibility
What is being tested?
The study tests if dulaglutide injections can reduce fat deposits in muscles and improve muscle function and physical performance in CKD patients. It's also checking the safety of using dulaglutide as an additional treatment over 12 weeks.See study design
What are the potential side effects?
Potential side effects include allergic reactions to dulaglutide, digestive issues like inflammation of the pancreas or gallstones due to its impact on fat metabolism and gastrointestinal functions.
GLIMP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is moderately to severely reduced.
Select...
I am between 18 and 75 years old.
GLIMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in intermuscular fat deposition as assessed by magnetic resonance imaging (MRI).
Changes in physical performance as assessed by six-minute walk test.
Changes in skeletal muscle mitochondrial function as assessed by phosphocreatine recovery time constant by 31P magnetic resonance spectroscopy (31P-MRS).
+1 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
GLIMP Trial Design
1Treatment groups
Experimental Treatment
Group I: dulagutide armExperimental Treatment1 Intervention
Patient will receive 1.5 mg injections per week for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,183 Total Patients Enrolled
Nashville VA Medical CenterUNKNOWN
2 Previous Clinical Trials
534 Total Patients Enrolled
Alp Ikizler, MDPrincipal InvestigatorVanderbilt University Medical Center
19 Previous Clinical Trials
1,246 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My HbA1c was over 8% recently, or I've had low blood sugar or diabetic ketoacidosis in the past year.I have had major gut surgery or have gut inflammation, pancreatitis, or gallstones.My high blood pressure is not controlled even with medication.I have an ongoing infection.I have had a kidney transplant.You are uncomfortable in tight spaces or have reasons that prevent you from getting a magnetic resonance imaging (MRI) scan.My kidney function is moderately to severely reduced.I do not have severe heart conditions like arrhythmia, heart failure, or valve disease.I am between 18 and 75 years old.I have type 2 diabetes and am on insulin or started a new diabetes medication recently.I have not had cancer or chemotherapy in the last 3 years.I or my family have a history of medullary thyroid cancer or I have MEN-2.Your body mass index (BMI) is either below 25 or above 40.You are allergic to dulaglutide.I have not taken corticosteroids in the last 3 months.I have type 1 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: dulagutide arm
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration approved dulaglutide injection for clinical use?
"With only preliminary data on its safety, dulaglutide injection musters a score of 2. There is no evidence yet to indicate efficacy."
Answered by AI
Does the prescribed criteria for this experiment encompass individuals over sixty years old?
"This medical trial is looking for participants between 18 and 75 years of age. Separate studies exist for younger or older individuals, with 43 trials available to those below the legal limit and 457 geared towards seniors."
Answered by AI
Is it possible to take part in this research endeavor?
"This particular trial is seeking 10 participants who suffer from chronic kidney disease (CKD) in the range of stage 3 to 4 and have an estimated glomerular filtration rate between 15-59 ml/min/1.73 m2, all while being aged 18-75 years old."
Answered by AI
Are there any remaining spots available in this research project?
"Data hosted on clinicaltrials.gov indicates that this research endeavour is actively recruiting patients, with the original posting occurring on March 15th 2022 and a recent edit conducted on March 20th 2022."
Answered by AI
What is the total enrollment size of this clinical investigation?
"Affirmative. According to the information posted on clinicaltrials.gov, this research is currently enrolling participants - it was initially announced on March 15th 2022 and has been edited as recently as March 20th 2022. 10 individuals are needed at one site for completion of the trial."
Answered by AI
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