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Active, Not Recruiting

NCT Number: NCT06709313

Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

FAYOUM University hospital

Al Fayyum, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chromium

Drug

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 names: Chromium picolinate

Primary outcomes

  1. Random blood sugar

    Time frame: 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 outcomes

  1. Oral hypoglycemic drug dose

    Time frame: 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.

  2. Total analgesic consumption

    Time frame: Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.

    It will be assessed through participant self-reporting and clinical evaluation.

  3. Vas Score

    Time frame: 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').

  4. Side effects of chromium supplementation

    Time frame: Post-intervention for 3 months

    According to isolated case reports, chromium supplements might cause gastrointestinal symptoms, weight loss, anemia, allergy.

  5. HbA1c

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Does Oral Chromium Withstand Steroid Hyperglycemia in Post-interventional Ultrasound Guided Sacroiliac Joint Injection in Diabetic Patients

Acronym: Cr

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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