Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection

Phase 4

Active, not recruiting

• Conditions: Sacro Iliac Joint Pain; Diabetes
• Interventions: Drug: Chromium

• Registration Number: NCT06709313
• Lead Sponsor: Fayoum University

Brief Summary

The aim of this study is to investigate whether oral chromium supplementation can decrease steroid-induced hyperglycemia in diabetic patients undergoing ultrasound-guided sacroiliac joint injections through a randomized controlled trial (RCT).

Detailed Description

One of the most prevalent complaints these days is sacroiliitis, which affects around 20% of the population.

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.

Study Timeline

• Study Start: 2024-06-03
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-01
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients (age ≥ 18 years).
• Diagnosed with diabetes mellitus.
• Scheduled for ultrasound-guided sacroiliac joint injections for pain management.

Exclusion Criteria

• Patients with contraindications to chromium supplementation like people with kidney or liver disorders or people with iron deficiency.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chromium group	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.

Primary Outcome Measures

Name	Time	Method
Random blood sugar	Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks	Blood glucose levels will be measured using a glucometer or laboratory analysis.

Secondary Outcome Measures

Name	Time	Method
Oral hypoglycemic drug dose	Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks	It will be assessed through participant self-reporting and clinical evaluation.
Total analgesic consumption	Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.	It will be assessed through participant self-reporting and clinical evaluation.
Vas Score	Post-intervention at 1 Month, 3 Months, 6 Months	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Side effects of chromium supplementation	Post-intervention for 3 months	According to isolated case reports, chromium supplements might cause gastrointestinal symptoms, weight loss, anemia, allergy.
HbA1c	Pre-intervention and at 6 weeks after intervention	Glycated hemoglobin test is a blood test that shows what your average blood sugar level was over the past two to three months.

Trial Locations

Locations (1)

FAYOUM University hospital; 🇪🇬 Fayoum, Egypt