Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
DOTAFLAME
1 other identifier
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes
Started Jan 2023
Shorter than P25 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMay 9, 2023
May 1, 2023
1.2 years
October 14, 2022
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in coronary 68Ga-Dotatate uptake after treatment.
The within subject comparison of 68Ga-Dotatate uptake in the coronary arteries before and after semaglutide treatment, expressed as a difference in TBRmax.
6 months
Secondary Outcomes (1)
Difference in bone marrow aspirates after treatment.
6 months
Study Arms (1)
Treatment arm
EXPERIMENTALWill receive semaglutide treatment for 6 months, at the highest tolerable dose, up to a maximum of 2.0mg weekly.
Interventions
Semaglutide 2.0 mg/mL, administered subcutaneously once per week for a period of 6 months.
Eligibility Criteria
You may qualify if:
- Age \>50 years old
- Diagnosed with type 2 diabetes
- HbA1c \>64mmol/mol
You may not qualify if:
- (History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- 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
- Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.
- Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- Uncontrolled hypertension (systolic blood pressure \> 180mmHg, diastolic blood pressure \> 100mmHg)
- Uncontrolled chronic inflammatory conditions, including gout.
- Women of childbearing age who are not using effective contraceptives.
- Heart failure New York Heart Association (NYHA) class IV at screening visit.
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.
- Pancreatitis in medical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AMC
Amsterdam, North Holland, 1105AZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 27, 2022
Study Start
January 1, 2023
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
May 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share