Clinical trial NCT06709313: Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection
Official title: Does Oral Chromium Withstand Steroid Hyperglycemia in Post-interventional Ultrasound Guided Sacroiliac Joint Injection in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Sacro Iliac Joint Pain
Diabetes
Keywords: Chromium
Sacroiliac joint injection
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups:

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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Random blood sugar
timeFrame: Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks
Secondary outcomes:
measure: Oral hypoglycemic drug dose
timeFrame: Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks
measure: Total analgesic consumption
timeFrame: Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.
measure: Vas Score
timeFrame: Post-intervention at 1 Month, 3 Months, 6 Months
measure: Side effects of chromium supplementation
timeFrame: Post-intervention for 3 months
measure: HbA1c
timeFrame: Pre-intervention and at 6 weeks after intervention
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: FAYOUM University hospital
Study officials:
affiliation: Faculty of medicine, Fayoum university
name: Mohamed A Hamed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, Fayoum university
name: Atef M Sayed, MD
role: PRINCIPAL_INVESTIGATOR
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