Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection
NCT ID: NCT06709313
Last Updated: 2024-11-29
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-06-03
2025-05-31
Brief Summary
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Detailed Description
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In roughly 10% to 27% of these cases, the sacroiliac joint has been identified as the major source of pain.
Due to the interrelated causes of facet joint and intervertebral disc pain, a precise diagnosis of sacroiliac joint pain is difficult. Imaging methods, controlled local anesthetic blocks, history taking, and physical examinations can all be used to make a diagnosis.
When people are unable to have surgery because of challenges with their health or other issues, steroids can be used to alleviate severe pain that has to be treated surgically. However, using steroids can have a number of negative consequences, including exhaustion, nausea, face flushing, and fever. One common steroid side effect is the Elevation of blood glucose levels which can be challenging to diabetic patients.
The hypothalamic-pituitary-adrenal (HPA) axis can be inhibited by the administration of steroids, which puts patients at risk for adrenal insufficiency and makes blood glucose management difficult , as it also raises the random blood sugar levels. Additionally, it can increase insulin resistance and blood glucose levels by suppressing the activity of glucose metabolism and promoting gluconeogenesis.
As a result, investigating a way to reduce the difficulty and minimize complications for people with diabetes is needed..
In comparison to those without diabetes mellitus (DM), patients with DM are more susceptible to vascular damage, joint and disk abnormalities, and degenerative changes. They also have a greater frequency of illnesses affecting the shoulders and spine. Because steroid usage increases the risk of high blood glucose in individuals with diabetes mellitus, the active use of steroids in clinical practice is restricted.
Blood glucose rise following steroid injection in particular regions, such as the wrist, finger, shoulder, and knee, has been the subject of many investigations recently.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Experimental Group:
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
Control Group: Participants will not receive chromium after sacroiliac joint injection.
TREATMENT
SINGLE
Study Groups
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chromium group
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
Chromium
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
Non chromium group
Participants will not receive chromium after sacroiliac joint injection.
No interventions assigned to this group
Interventions
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Chromium
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with diabetes mellitus.
* Scheduled for ultrasound-guided sacroiliac joint injections for pain management.
Exclusion Criteria
* Patients with a history of chromium allergy.
* Pregnant or lactating women.
* Patients with uncontrolled diabetes (HbA1c \> 9%).
* Cardiac, renal, hepatic, coagulopathy.
* Lumbar Spine deformity.
* Obesity BMI ( 35 kg/m²)
* Local infection.
18 Years
ALL
No
Sponsors
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Fayoum University
OTHER
Responsible Party
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Mohamed Ahmed Hamed
Associate Professor of Anesthesiology
Principal Investigators
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Mohamed A Hamed, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of medicine, Fayoum university
Atef M Sayed, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of medicine, Fayoum university
Locations
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FAYOUM University hospital
Al Fayyum, , Egypt
Countries
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References
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Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol Int. 2019 Apr;39(4):619-626. doi: 10.1007/s00296-019-04273-0. Epub 2019 Mar 8.
Simopoulos TT, Manchikanti L, Singh V, Gupta S, Hameed H, Diwan S, Cohen SP. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012 May-Jun;15(3):E305-44.
Hancock MJ, Maher CG, Latimer J, Spindler MF, McAuley JH, Laslett M, Bogduk N. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007 Oct;16(10):1539-50. doi: 10.1007/s00586-007-0391-1. Epub 2007 Jun 14.
Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.
Habib GS, Miari W. The effect of intra-articular triamcinolone preparations on blood glucose levels in diabetic patients: a controlled study. J Clin Rheumatol. 2011 Sep;17(6):302-5. doi: 10.1097/RHU.0b013e31822acd7c.
Hart L. Corticosteroid and other injections in the management of tendinopathies: a review. Clin J Sport Med. 2011 Nov;21(6):540-1. doi: 10.1097/01.jsm.0000407929.35973.b9.
Stepan JG, London DA, Boyer MI, Calfee RP. Blood glucose levels in diabetic patients following corticosteroid injections into the hand and wrist. J Hand Surg Am. 2014 Apr;39(4):706-12. doi: 10.1016/j.jhsa.2014.01.014.
Even JL, Crosby CG, Song Y, McGirt MJ, Devin CJ. Effects of epidural steroid injections on blood glucose levels in patients with diabetes mellitus. Spine (Phila Pa 1976). 2012 Jan 1;37(1):E46-50. doi: 10.1097/BRS.0b013e31821fd21f.
Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Freeman TL, Slaten WK. Complications of fluoroscopically guided transforaminal lumbar epidural injections. Arch Phys Med Rehabil. 2000 Aug;81(8):1045-50. doi: 10.1053/apmr.2000.7166.
Donatti TL, Koch VH, Takayama L, Pereira RM. Effects of glucocorticoids on growth and bone mineralization. J Pediatr (Rio J). 2011 Jan-Feb;87(1):4-12. doi: 10.2223/JPED.2052. Epub 2011 Jan 13. English, Portuguese.
Duclos M, Guinot M, Colsy M, Merle F, Baudot C, Corcuff JB, Lebouc Y. High risk of adrenal insufficiency after a single articular steroid injection in athletes. Med Sci Sports Exerc. 2007 Jul;39(7):1036-43. doi: 10.1249/mss.0b013e31805468d6.
Iwamoto T, Kagawa Y, Naito Y, Kuzuhara S, Kojima M. Steroid-induced diabetes mellitus and related risk factors in patients with neurologic diseases. Pharmacotherapy. 2004 Apr;24(4):508-14. doi: 10.1592/phco.24.5.508.33355.
Lotan R, Oron A, Anekstein Y, Shalmon E, Mirovsky Y. Lumbar stenosis and systemic diseases: is there any relevance? J Spinal Disord Tech. 2008 Jun;21(4):247-51. doi: 10.1097/BSD.0b013e31813707af.
Jeffcoate WJ, Game F, Cavanagh PR. The role of proinflammatory cytokines in the cause of neuropathic osteoarthropathy (acute Charcot foot) in diabetes. Lancet. 2005 Dec 10;366(9502):2058-61. doi: 10.1016/S0140-6736(05)67029-8. Epub 2005 Aug 10.
Xu G, Pierson CR, Murakawa Y, Sima AA. Altered tubulin and neurofilament expression and impaired axonal growth in diabetic nerve regeneration. J Neuropathol Exp Neurol. 2002 Feb;61(2):164-75. doi: 10.1093/jnen/61.2.164.
Aleem AW, Syed UAM, Nicholson T, Getz CL, Namdari S, Beredjiklian PK, Abboud JA. Blood Glucose Levels in Diabetic Patients Following Corticosteroid Injections into the Subacromial Space of the Shoulder. Arch Bone Jt Surg. 2017 Sep;5(5):315-321.
Suksomboon N, Poolsup N, Yuwanakorn A. Systematic review and meta-analysis of the efficacy and safety of chromium supplementation in diabetes. J Clin Pharm Ther. 2014 Jun;39(3):292-306. doi: 10.1111/jcpt.12147. Epub 2014 Mar 17.
Other Identifiers
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M725
Identifier Type: -
Identifier Source: org_study_id