Does Oral Chromium Withstand Steroid Hyperglycemia in Post-interventional Ultrasound Guided Sacroiliac Joint Injection in Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Random blood sugar
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years).
- •Diagnosed with diabetes mellitus.
- •Scheduled for ultrasound-guided sacroiliac joint injections for pain management.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Chromium (Drug)
结局指标
主要结局
Random blood sugar
时间窗: 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.
次要结局
- Oral hypoglycemic drug dose(Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks)
- Total analgesic consumption(Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.)
- Vas Score(Post-intervention at 1 Month, 3 Months, 6 Months)
- Side effects of chromium supplementation(Post-intervention for 3 months)
- HbA1c(Pre-intervention and at 6 weeks after intervention)
研究者
Mohamed Ahmed Hamed
Associate Professor of Anesthesiology
Fayoum University