NCT06011512

Brief Summary

The goal of this observational study is to expand the knowledge about development and aggreviation of diabetes mellitus in patients with giant cell arthritis and polymyalgia rheumatica. The main questions it aims to answer are:

  • To identify the risk of comorbidities, especially diabetes, in patients with giant cell arthritis and polymyalgia rheumatica, treated with glucocorticoids in combination with or without interleukin-6 inhibitor.
  • To identify clinical outcomes and biomarkers as potential predictors for development or aggregation of already existing diabetes mellitus in patients with giant cell arthritis or polymyalgia rheumatica using machine learning prediction. Participants will be followed at their respective rheumatology clinic, and will be asked to deliver blood samples at predefined visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

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

August 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

August 10, 2023

Last Update Submit

April 24, 2026

Conditions

Giant Cell ArteritisPolymyalgia RheumaticaLarge Vessel Vasculitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants developing diabetes mellitus during the study period, measured in changes of HbA1c.

    HbA1c is glycated hemoglobin, which means that hemoglobin is chemically bound to glucose in the bloodstream. HbA1c is a relative measure of the average glucose in the bloodstream during the past 3 months, and is used to diagnose patients with diabetes mellitus.

    At baseline, and month 1, 3, 6, 12, 24 and 36.

Secondary Outcomes (13)

  • Changes in CD36.

    At baseline, and month 1, 3, 6, 12, 24 and 36.

  • Changes in sCD36.

    At baseline, and month 1, 3, 6, 12, 24 and 36.

  • Changes in homeostatic model assessment for insulin resistance.

    At baseline, and month 1, 3, 6, 12, 24 and 36.

  • Changes in proinsulin C-peptide.

    At baseline, and month 1, 3, 6, 12, 24 and 36.

  • Changes in fasting proinsulin C-peptide.

    At baseline, and month 1, 3, 6, 12, 24 and 36.

  • +8 more secondary outcomes

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population from which the cohort will be selected from, are patients who are treated at their respective outpatient rheumatology clinic. At least 8 departments of rheumatlogy in Denmark are expected to include patients.

You may qualify if:

  • Men or women aged 50 to 85 years
  • Are diagnosed with GCA or PMR
  • Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
  • Speak and understand Danish
  • Are able to give signed and dated informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Giant Cell ArteritisPolymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue Diseases

Study Officials

  • Salome Kristensen, MD, PhD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 25, 2023

Study Start

August 1, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

DK(1)