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

September 26, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus

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

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • AP-HP, Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients recruited in five rheumatology departments

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
rheumatoid arthritis and type 2 diabetes
osteoarthritis and type 2 diabetes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Investigators

  • Principal Investigator: Jérôme Avouac, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2016

Primary Completion (Anticipated)

April 13, 2024

Study Completion (Anticipated)

April 13, 2024

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI15005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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