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

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ClinicalTrials.gov Identifier: NCT02639988
Recruitment Status : Recruiting
First Posted : December 28, 2015
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Information provided by (Responsible Party):
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

Condition or disease
Type 2 Diabetes

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus
Actual Study Start Date : April 13, 2016
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Glycated haemoglobin (HbA1c) levels in % [ Time Frame: two years ]
  2. Insulin resistance (HOMA-IR), absolute value [ Time Frame: two years ]
  3. Proportion of patients requesting insulin in % [ Time Frame: two years ]
  4. Proportion of patients with type 2 diabetes-related acute complications in % [ Time Frame: two years ]
  5. Proportion of patients requiring the addition of a new treatment for type 2 diabetes in % [ Time Frame: five years ]
  6. Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in % [ Time Frame: five years ]
  7. Proportion of patients with increased HOMA-IR between 2 visits in % [ Time Frame: five years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients recruited in five rheumatology departments
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639988


Contacts
Contact: Jérôme Avouac, MD, PhD +33 1 58412563 jerome.avouac@aphp.fr
Contact: Valérie Fauroux +33 1 58 441 12 13 valerie.fauroux@aphp.fr

Locations
France
AP-HP, Cochin hospital Recruiting
Paris, France, 75014
Contact: Jerôme Avouac, MD, PhD    +33158412563    jerome.avouac@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Investigators
Principal Investigator: Jérôme Avouac, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02639988     History of Changes
Other Study ID Numbers: NI15005
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
type 2 diabetes mellitus
Rheumatoid arthritis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Arthritis
Arthritis, Rheumatoid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases