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Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
Plain-language guide to NCT05597202: phase 4 interventional trial of Semaglutide, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05597202
- Phase
- phase 4
- Status
- status unknown
- Start
- 2023-01-01
- Completion (planned or actual)
- 2024-03
- Participants
- 22 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Semaglutide.
To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.
It had 1 arm (groups): Treatment arm (experimental).
The registry classes the interventions as drug.
Who Took Part
22 planned participants were the target.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age \>50 years old. Diagnosed with type 2 diabetes.
The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: chronic or recent infections and/or clinical signs of infection and/or a plasma c-reactive protein above 10ng/ml; auto-immune diseases (including type 1 diabetes); recent or chronic immunosuppressant or antibiotic usage.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Semaglutide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-01-01 with completion listed for 2024-03.
It ran at 1 site in Netherlands.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Difference in coronary 68Ga-Dotatate uptake after treatment (time frame: 6 months).
It also tracked 1 secondary outcome, for example Difference in bone marrow aspirates after treatment.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Semaglutide in 22 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
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.