The effect of statin treatment on arterial wall inflammation in patients with diabetes measured by 68Ga DOTATATE PET-CT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20201

Enrollment

Registered

2019-05-16

Start date

2019-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Diabetes mellitus type 2

Interventions

Atorvastatin 40 mg once daily

Eligibility

Inclusion criteria

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.(22) 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

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 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.

Design outcomes

Primary

Measure	Time frame
The main objective of this study is to assess the extent of increased wall inflammation of patients with diabetes mellitus type-2 with 68Ga-Dotatate PET-CT and to assess the difference in 68Ga-Dotatate arterial wall inflammation after three months of atorvastatin 40mg therapy. • The main study parameter will be the 68Ga-Dotatate uptake, expressed as targetto-background ratio (TBR) in the carotid arteries and aorta.	—

Measure

Time frame

The main objective of this study is to assess the extent of increased wall inflammation of patients with diabetes mellitus type-2 with 68Ga-Dotatate PET-CT and to assess the difference in 68Ga-Dotatate arterial wall inflammation after three months of atorvastatin 40mg therapy. • The main study parameter will be the 68Ga-Dotatate uptake, expressed as targetto-background ratio (TBR) in the carotid arteries and aorta.

—

Secondary

Measure	Time frame
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 the target-to-background ratio (TBR)	—

Contacts

Public ContactYannick Kaiser

Amsterdam University Medical Centers, location AMC

y.kaiser@amsterdamumc.nl0205668675

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)