Clinical trial NCT02639988: Impact of Rheumatoid Arthritis on the Course of Type 2 Diabetes During a Longitudinal Follow-up of 5 Years
Official title: Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes mellitus
Rheumatoid arthritis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
First posted: 2015-12-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients recruited in five rheumatology departments

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to the addition of a new treatment for type 2 diabetes in months
timeFrame: five years
Secondary outcomes:
measure: Glycated haemoglobin (HbA1c) levels in %
timeFrame: two years
measure: Insulin resistance (HOMA-IR), absolute value
timeFrame: two years
measure: Proportion of patients requesting insulin in %
timeFrame: two years
measure: Proportion of patients with type 2 diabetes-related acute complications in %
timeFrame: two years
measure: Proportion of patients requiring the addition of a new treatment for type 2 diabetes in %
timeFrame: five years
measure: Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in %
timeFrame: five years
measure: Proportion of patients with increased HOMA-IR between 2 visits in %
timeFrame: five years
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Cochin hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jérôme Avouac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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