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

Suspended

• Conditions: Type 2 Diabetes

• Registration Number: NCT02639988
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Study Start: 2016-04-13
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27
• Primary Completion: 2024-04-13
• Study Completion: 2024-04-13

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

AP-HP, Cochin hospital; 🇫🇷 Paris, France