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

NCT ID: NCT02639988

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-13

Study Completion Date

2022-05-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rheumatoid arthritis and type 2 diabetes

No interventions assigned to this group

osteoarthritis and type 2 diabetes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme Avouac, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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AP-HP, Cochin hospital

Paris, Paris, France

Site Status

Countries

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France

References

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Meune C, Touze E, Trinquart L, Allanore Y. High risk of clinical cardiovascular events in rheumatoid arthritis: Levels of associations of myocardial infarction and stroke through a systematic review and meta-analysis. Arch Cardiovasc Dis. 2010 Apr;103(4):253-61. doi: 10.1016/j.acvd.2010.03.007. Epub 2010 May 18.

Reference Type BACKGROUND
PMID: 20656636 (View on PubMed)

Meune C, Touze E, Trinquart L, Allanore Y. Trends in cardiovascular mortality in patients with rheumatoid arthritis over 50 years: a systematic review and meta-analysis of cohort studies. Rheumatology (Oxford). 2009 Oct;48(10):1309-13. doi: 10.1093/rheumatology/kep252. Epub 2009 Aug 20.

Reference Type BACKGROUND
PMID: 19696061 (View on PubMed)

Liao KP, Solomon DH. Traditional cardiovascular risk factors, inflammation and cardiovascular risk in rheumatoid arthritis. Rheumatology (Oxford). 2013 Jan;52(1):45-52. doi: 10.1093/rheumatology/kes243. Epub 2012 Sep 16.

Reference Type BACKGROUND
PMID: 22986289 (View on PubMed)

Reilly MP, Wolfe ML, Rhodes T, Girman C, Mehta N, Rader DJ. Measures of insulin resistance add incremental value to the clinical diagnosis of metabolic syndrome in association with coronary atherosclerosis. Circulation. 2004 Aug 17;110(7):803-9. doi: 10.1161/01.CIR.0000138740.84883.9C. Epub 2004 Aug 2.

Reference Type BACKGROUND
PMID: 15289378 (View on PubMed)

Chung CP, Oeser A, Solus JF, Gebretsadik T, Shintani A, Avalos I, Sokka T, Raggi P, Pincus T, Stein CM. Inflammation-associated insulin resistance: differential effects in rheumatoid arthritis and systemic lupus erythematosus define potential mechanisms. Arthritis Rheum. 2008 Jul;58(7):2105-12. doi: 10.1002/art.23600.

Reference Type BACKGROUND
PMID: 18576352 (View on PubMed)

Dessein PH, Joffe BI. Insulin resistance and impaired beta cell function in rheumatoid arthritis. Arthritis Rheum. 2006 Sep;54(9):2765-75. doi: 10.1002/art.22053.

Reference Type BACKGROUND
PMID: 16947779 (View on PubMed)

Ashida R, Ihn H, Mimura Y, Jinnin M, Asano Y, Kubo M, Tamaki K. Clinical features of scleroderma patients with contracture of phalanges. Clin Rheumatol. 2007 Aug;26(8):1275-7. doi: 10.1007/s10067-006-0490-0. Epub 2006 Dec 15.

Reference Type BACKGROUND
PMID: 17171315 (View on PubMed)

Kiortsis DN, Mavridis AK, Vasakos S, Nikas SN, Drosos AA. Effects of infliximab treatment on insulin resistance in patients with rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2005 May;64(5):765-6. doi: 10.1136/ard.2004.026534. Epub 2004 Sep 30.

Reference Type BACKGROUND
PMID: 15458960 (View on PubMed)

Rosenvinge A, Krogh-Madsen R, Baslund B, Pedersen BK. Insulin resistance in patients with rheumatoid arthritis: effect of anti-TNFalpha therapy. Scand J Rheumatol. 2007 Mar-Apr;36(2):91-6. doi: 10.1080/03009740601179605.

Reference Type BACKGROUND
PMID: 17476613 (View on PubMed)

Solomon DH, Massarotti E, Garg R, Liu J, Canning C, Schneeweiss S. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011 Jun 22;305(24):2525-31. doi: 10.1001/jama.2011.878.

Reference Type BACKGROUND
PMID: 21693740 (View on PubMed)

Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4.

Reference Type BACKGROUND
PMID: 17145742 (View on PubMed)

Arrieta F, Pinera M, Iglesias P, Nogales P, Salinero-Fort MA, Abanades JC, Botella-Carretero JI, Calanas A, Balsa JA, Zamarron I, Rovira A, Vazquez C; ESD2 Group. Metabolic control and chronic complications during a 3-year follow-up period in a cohort of type 2 diabetic patients attended in primary care in the Community of Madrid (Spain). Endocrinol Nutr. 2014 Jan;61(1):11-7. doi: 10.1016/j.endonu.2013.09.002. Epub 2013 Oct 30.

Reference Type BACKGROUND
PMID: 24182687 (View on PubMed)

Other Identifiers

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NI15005

Identifier Type: -

Identifier Source: org_study_id

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