The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Vascular Inflammation
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet

• Registration Number: NCT05730634
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

To study the effect of atorvastatin treatment on vascular uptake of 68Ga-DOTATATE in patients with Type 2 Diabetes.

Detailed Description

Well controlled patients with type 2 diabetes, who are statin naïve, will undergo atorvastatin treatment. Before and after treatment, patients will undergo a 68Ga-DOTATATE PET/CT, to evaluate the effect of treatment on vascular inflammation.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2022-05-06
• Study Completion: 2022-05-06
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Aged 50 years and older
2. Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy.
3. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2.
4. HbA1c values below 65 mmol/L.
5. Patients with "stable" diabetes mellitus, i.e. no changes in type of glucose lowering therapy and / or dosage of oral glucose lowering therapy in the past three months. No more than 20% change in dosage of insulin therapy (short and long acting) in the last three months.

Exclusion Criteria

1. History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome).

2. History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m2

3. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.

4. Chronic or recent (< 1 month) infections and/or clinical signs of acute infection.

5. History of auto-immune diseases.

6. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.

7. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

8. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.

9. Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known liver disease.

10. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e.

    (severe) muscle pains with and/or without myopathy .

11. The concomitant use of statin contra-indicated drugs, including the use of CYP3A4 inhibitors (i.e. erytromycin, dilthiazem, amiodaron, verapamil, fluconazole, ciclosporin, stiripentol, itraconazol, ketoconazol, voriconazol, posaconazol, clarithromycin, ..), systemic use of fusidic acid and ciclosporin.

12. Any contra-indications to the use of statins.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Atorvastatin 40 Mg Oral Tablet	Atorvastatin 40mg once daily.

Primary Outcome Measures

Name	Time	Method
DOTATATE coronary arteries	3 months	Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy

Secondary Outcome Measures

Name	Time	Method
Change in splenic/bone marrow DOTATATE signal	3 month	The secondary objective of this study is to assess the feasibility to measure splenic and bone-marrow inflammatory activity with 68Ga-Dotatate PET-CT in patients with diabetes mellitus, expressed as SUVmax

Trial Locations

Locations (1)

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands