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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-05-06

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Vascular Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention arm

Atorvastatin 40mg once daily.

Group Type EXPERIMENTAL

Atorvastatin 40 Mg Oral Tablet

Intervention Type DRUG

Atorvastatin 40mg once daily for three months

Interventions

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Atorvastatin 40 Mg Oral Tablet

Atorvastatin 40mg once daily for three months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No