Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05597202

Acronym

DOTAFLAME

Enrollment

Registered

2022-10-27

Start date

2023-01-01

Completion date

2024-04-30

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

diabetes mellitus, dotatate, bone marrow, semaglutide, vascular inflammation, glp1

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.

Detailed description

We will use 68Ga-Dotatate PET/CT scans, bone marrow aspirations and peripheral blood analyses to determine the effect of type 2 diabetes on vascular wall inflammation, and hematopoietic stem cell composition, and whether these changes can be reversed using high dose semaglutide treatment, up to 2.0mg subcutaneously per week, for a period of six months.

Interventions

DRUGSemaglutide, 2.0 mg/mL

Semaglutide 2.0 mg/mL, administered subcutaneously once per week for a period of 6 months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>50 years old * Diagnosed with type 2 diabetes * HbA1c \>64mmol/mol

Exclusion criteria

1. (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. 2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml 3. Auto-immune diseases (including type 1 diabetes) 4. Recent or chronic immunosuppressant or antibiotic usage 5. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists. 6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. 7. Uncontrolled hypertension (systolic blood pressure \> 180mmHg, diastolic blood pressure \> 100mmHg) 8. Uncontrolled chronic inflammatory conditions, including gout. 9. Women of childbearing age who are not using effective contraceptives. 10. Heart failure New York Heart Association (NYHA) class IV at screening visit. 11. 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. 12. Pancreatitis in medical history.

Design outcomes

Primary

Measure	Time frame	Description
Difference in coronary 68Ga-Dotatate uptake after treatment.	6 months	The within subject comparison of 68Ga-Dotatate uptake in the coronary arteries before and after semaglutide treatment, expressed as a difference in TBRmax.

Secondary

Measure	Time frame	Description
Difference in bone marrow aspirates after treatment.	6 months	The within subject comparison of bone marrow aspirates before and after semaglutide treatment, expressed as a difference in stem cell count.

Countries

Netherlands

Contacts

Primary ContactR.F. Oostveen, MD

r.oostveen@amsterdamumc.nl020 5667050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026