Rheumatoid Arthritis (RANCT06691997
The Impact of Glycemic Control on Rheumatoid Arthritis Disease Activity on Diabetic Patients
An observational study of Rheumatoid Arthritis (RA and Diabetes Mellitus, run by Assiut University at 1 site in Egypt.
Trial summary
The incidence of DM is unclear in RA but most prior data suggest that DM or insulin resistance in RA has risen because of activation of the immune system and/or RA therapy . Besides, RA causes joints to become stiff, swollen, and agonizing. As a result, the patient may not want to exercise or move. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA, Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2024to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients above age of 18 years old diagnosed with Rheumatoid Arthritis and DM
Who may be able to join
- type 2 diabetic patients
- rheumatoid arthritis patients
Who cannot join
- gestional diabetes
- type 1 diabetic patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Glycemic Control on Rheumatoid Arthritis Disease Activity in Diabetic Patients
The incidence of DM is unclear in RA but most prior data suggest that DM or insulin resistance in RA has risen because of activation of the immune system and/or RA therapy .
Besides, RA causes joints to become stiff, swollen, and agonizing. As a result, the patient may not want to exercise or move. One study found that 42% of people with RA are not physically active. the aim of this study is To evaluate the glycemic status among RA patients with Type 2 diabetes and its association with disease activity.
Read the detailed description
Taking the potential link between DM and RA into consideration, detection and control of DM will significantly increase prolonged prognosis and therefore decrease the economic burden of RA patients and death rate. The aim of this research is to examine diabetic RA's glycemic status and to assess the relationship between RA and DM's clinical characteristics as well as the therapy response in RA patients with diagnosed DM. Keeping an eye on glycemic control in RA patients could prevent metabolic and cardiovascular comorbidities in those susceptible patients.
- Conditions
- Rheumatoid Arthritis (RA, Diabetes Mellitus
- Keywords
- glycemic control
- Medical subject headings
- Arthritis, Rheumatoid, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | RA patients with Type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
correlation between type 2 diabetes control and rheumatoid arthritis activity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start12 Dec 2024 (estimated)
- Primary completion14 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khedr Nady Abd Elaziz, Assiut University
- Investigators
- Ahmed khedr Nady, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691997
- Sponsor's protocol ID
- DM and Rheumatoid Arthritis
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: According to result of search
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Glycemic Control on Rheumatoid Arthritis Disease Activity in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06691997
- Acronym / sponsor ID
- DM and Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis (RA, Diabetes Mellitus
- Keywords
- glycemic control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (estimated)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of DM is unclear in RA but most prior data suggest that DM or insulin resistance in RA has risen because of activation of the immune system and/or RA therapy .
Besides, RA causes joints to become stiff, swollen, and agonizing. As a result, the patient may not want to exercise or move. One study found that 42% of people with RA are not physically active. the aim of this study is To evaluate the glycemic status among RA patients with Type 2 diabetes and its association with disease activity.
Detailed description
Taking the potential link between DM and RA into consideration, detection and control of DM will significantly increase prolonged prognosis and therefore decrease the economic burden of RA patients and death rate. The aim of this research is to examine diabetic RA's glycemic status and to assess the relationship between RA and DM's clinical characteristics as well as the therapy response in RA patients with diagnosed DM. Keeping an eye on glycemic control in RA patients could prevent metabolic and cardiovascular comorbidities in those susceptible patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –RA patients with Type 2 diabetes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above age of 18 years old diagnosed with Rheumatoid Arthritis and DM
Key inclusion criteria (2 listed)
- type 2 diabetic patients
- rheumatoid arthritis patients
Key exclusion criteria (2 listed)
- gestional diabetes
- type 1 diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fasting blood glucose
Time frame: baseline
correlation between type 2 diabetes control and rheumatoid arthritis activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Wasserman A. Rheumatoid Arthritis: Common Questions About Diagnosis and Management. Am Fam Physician. 2018 Apr 1;97(7):455-462. PMID: 29671563.Link provided by the sponsor.
- Almutairi KB, Nossent JC, Preen DB, Keen HI, Inderjeeth CA. The Prevalence of Rheumatoid Arthritis: A Systematic Review of Population-based Studies. J Rheumatol. 2021 May;48(5):669-676. doi: 10.3899/jrheum.200367. Epub 2020 Oct 15. PMID: 33060323.Link provided by the sponsor.
- Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, MeasLink provided by the sponsor.
- Schoels M, Knevel R, Aletaha D, Bijlsma JWJ, Breedveld FC, Boumpas DT, Burmester G, Combe B, Cutolo M, Dougados M, Emery P, van der Heijde D, Huizinga TWJ, Kalden J, Keystone EC, Kvien TK, Martin-Mola E, Montecucco C, de Wit M, Smolen JS. Evidence for trLink provided by the sponsor.
- Jiang P, Li H, Li X. Diabetes mellitus risk factors in rheumatoid arthritis: a systematic review and meta-analysis. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):115-21. Epub 2014 Dec 22. PMID: 25535750.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. According to result of search
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed khedr Nady principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA and Diabetes Mellitus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed khedr Nady (+201097613616, ahmed.16266234@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.