Type 2 Diabetes Clinical Trial
— INSPIREDOfficial title:
Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus
| NCT number | NCT02639988 |
| Other study ID # | NI15005 |
| Secondary ID | |
| Status | Suspended |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 13, 2016 |
| Est. completion date | April 13, 2024 |
| Verified date | September 2022 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Suspended |
| Enrollment | 1000 |
| Est. completion date | April 13, 2024 |
| Est. primary completion date | April 13, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | AP-HP, Cochin hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Recherche Clinique Paris Descartes Necker Cochin Sainte Anne |
France,
Arrieta F, Piñera M, Iglesias P, Nogales P, Salinero-Fort MA, Abanades JC, Botella-Carretero JI, Calañas A, Balsa JA, Zamarrón I, Rovira A, Vázquez 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. — View Citation
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. Epub 2006 Dec 15. — View Citation
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. — View Citation
Dessein PH, Joffe BI. Insulin resistance and impaired beta cell function in rheumatoid arthritis. Arthritis Rheum. 2006 Sep;54(9):2765-75. — View Citation
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. Epub 2006 Dec 4. Erratum in: N Engl J Med. 2007 Mar 29;356(13):1387-8. — View Citation
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. Epub 2004 Sep 30. — View Citation
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. Review. — View Citation
Meune C, Touzé 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. Review. — View Citation
Meune C, Touzé 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. Review. — View Citation
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. Epub 2004 Aug 2. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to the addition of a new treatment for type 2 diabetes in months | addition of a new treatment includes insulin requirement | five years | |
| Secondary | Glycated haemoglobin (HbA1c) levels in % | two years | ||
| Secondary | Insulin resistance (HOMA-IR), absolute value | two years | ||
| Secondary | Proportion of patients requesting insulin in % | two years | ||
| Secondary | Proportion of patients with type 2 diabetes-related acute complications in % | two years | ||
| Secondary | Proportion of patients requiring the addition of a new treatment for type 2 diabetes in % | five years | ||
| Secondary | Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in % | five years | ||
| Secondary | Proportion of patients with increased HOMA-IR between 2 visits in % | five years |
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