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

Primary Purpose

Diabetes Mellitus, Type 2, Vascular Inflammation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Atorvastatin 40 Mg Oral Tablet
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 2 focused on measuring statin, dotatate, vascular inflammation, type 2 diabetes mellitus, pet/ct, positron emmission tomography

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 50 years and older Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2. HbA1c values below 65 mmol/L. 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: History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome). History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m2 Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. Chronic or recent (< 1 month) infections and/or clinical signs of acute infection. History of auto-immune diseases. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons. Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known liver disease. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e. (severe) muscle pains with and/or without myopathy . 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. Any contra-indications to the use of statins.

Sites / Locations

  • Amsterdam UMC, location AMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Atorvastatin 40mg once daily.

Outcomes

Primary Outcome Measures

DOTATATE coronary arteries
Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2023
Last Updated
February 7, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05730634
Brief Title
The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT
Acronym
CARAMEL
Official Title
The Effect of Statin Treatment on Arterial Wall Inflammation in Patients With Diabetes Mellitus as Assessed With 68Ga-DOTATATE PET-CT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
May 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Vascular Inflammation
Keywords
statin, dotatate, vascular inflammation, type 2 diabetes mellitus, pet/ct, positron emmission tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Atorvastatin 40mg once daily.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40 Mg Oral Tablet
Intervention Description
Atorvastatin 40mg once daily for three months
Primary Outcome Measure Information:
Title
DOTATATE coronary arteries
Description
Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in splenic/bone marrow DOTATATE signal
Description
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
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 50 years and older Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2. HbA1c values below 65 mmol/L. 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: History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome). History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m2 Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. Chronic or recent (< 1 month) infections and/or clinical signs of acute infection. History of auto-immune diseases. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons. Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known liver disease. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e. (severe) muscle pains with and/or without myopathy . 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. Any contra-indications to the use of statins.
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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