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Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease
Plain-language guide to NCT05254418: phase 2 interventional trial of Dulaglutide, 7 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05254418
- Phase
- phase 2
- Status
- completed
- Start
- 2022-03-15
- Completion (planned or actual)
- 2024-05-01
- Participants
- 7 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Chronic Kidney Diseases
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Dulaglutide.
Chronic kidney disease (CKD) is a burden of morbidity and mortality.
Insulin resistance plays a critical role in skeletal muscle wasting and ectopic fat deposition.
It had 1 arm (groups): dulagutide arm (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 7 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥ 18 years and ≤75 years.
The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: patients with type 1 diabetes mellitus; BMI \<25 kg/m2, BMI \>40 kg/m2; uncontrolled hypertension (\>200/100 mmhg) despite optimal antihypertensive therapy.
How the Study Was Run
Design: sequential and open-label.
Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2022-03-15 with completion listed for 2024-05-01.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Researchers chose this as the main measure: Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI) (time frame: 16 weeks). Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS) (time frame: 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 (time frame: 16 weeks).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Dulaglutide in 7 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Dulaglutide compound page, all human trials.
Our Notes on the Compound
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.