NCT05730634

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

February 7, 2023

Last Update Submit

February 7, 2023

Conditions

Diabetes Mellitus, Type 2Vascular Inflammation

Keywords

statindotatatevascular inflammationtype 2 diabetes mellituspet/ctpositron emmission tomography

Outcome Measures

Primary Outcomes (1)

  • DOTATATE coronary arteries

    Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy

    3 months

Secondary Outcomes (1)

  • Change in splenic/bone marrow DOTATATE signal

    3 month

Study Arms (1)

Intervention arm

EXPERIMENTAL

Atorvastatin 40mg once daily.

Drug: Atorvastatin 40 Mg Oral Tablet

Interventions

Atorvastatin 40 Mg Oral TabletDRUG

Atorvastatin 40mg once daily for three months

Intervention arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

  • Oostveen RF, Kaiser Y, Stahle MR, Nurmohamed NS, Tzolos E, Dweck MR, Kroon J, Murphy AJ, Dey D, Slomka PJ, Verberne HJ, Stroes ESG, Hanssen NMJ. Atorvastatin lowers 68Ga-DOTATATE uptake in coronary arteries, bone marrow and spleen in individuals with type 2 diabetes. Diabetologia. 2023 Nov;66(11):2164-2169. doi: 10.1007/s00125-023-05990-9. Epub 2023 Aug 15.

    PMID: 37581619DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AtorvastatinTablets

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

June 1, 2019

Primary Completion

May 6, 2022

Study Completion

May 6, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)