Impact of Rheumatoid Arthritis on the Course of Type 2 Diabetes During a Longitudinal Follow-up of 5 Years

Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02639988

Acronym

INSPIRED

Enrollment

176

Registered

2015-12-28

Start date

2016-04-13

Completion date

2022-05-30

Last updated

2025-09-15

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

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes mellitus, Rheumatoid arthritis

Brief summary

The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients * Adults (\>18 years) * Rheumatoid arthritis fulfilling American College of Rheumatology (ACR )1987 or European League Against Rheumatism (ACR/EULAR) 2010 classification criteria * Type 2 diabetes (HbA1c ≥6.5% OR fasting glycemia≥7 mmol/l OR glycemia 120 min after 75 mg glucose ingestion ≥ 11.1 mmol/l OR symptoms of hyperglycemia with glycemia ≥11.1 mmol/l) * Affiliated to social security system Controls * Adults (\>18 years) matched for age, sex and BMI with patients with rheumatoid arthritis * Osteoarthritis (knee, hip, spine and hand) * Type 2 diabetes with disease duration matched with patients with rheumatoid arthritis * Affiliated to social security system

Exclusion criteria

* Patient not able to understand study implication and rules * Patient opposed to participate to the study * Transient diabetes * Gestational diabetes * Secondary diabetes

Design outcomes

Primary

Measure	Time frame	Description
Time to the addition of a new treatment for type 2 diabetes in months	five years	addition of a new treatment includes insulin requirement

Secondary

Measure	Time frame
Insulin resistance (HOMA-IR), absolute value	two years
Proportion of patients requesting insulin in %	two years
Proportion of patients with type 2 diabetes-related acute complications in %	two years
Glycated haemoglobin (HbA1c) levels in %	two years
Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in %	five years
Proportion of patients with increased HOMA-IR between 2 visits in %	five years
Proportion of patients requiring the addition of a new treatment for type 2 diabetes in %	five years

Countries

France

Outcome results