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

Diabetes Mellitus, Type 2 Clinical Trial

— CARAMEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05730634
• Other study ID #: NL65001.018.18
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 6, 2022

Study information

• Verified date: February 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Vascular Inflammation

Intervention

Drug:
• Atorvastatin 40 Mg Oral Tablet
Atorvastatin 40mg once daily for three months

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DOTATATE coronary arteries	Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy	3 months
Secondary	Change in splenic/bone marrow DOTATATE signal	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	3 month