Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Post-injection glucose levels
研究概览
简要总结
A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients at the Parkland Outpatient Clinic
- •Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis
排除标准
- •Less than 18 years old
- •HbA1c > 12.0%
- •steroid exposure in the 3 months prior to Visit 1
- •3 or more steroid injections in the preceding 12 months
- •known contraindication to steroid injection (adverse reaction or allergy, active infection, INR > 3.0)
- •lack of improvement with prior knee steroid injection
- •change in diabetic medication regimen in the last 1 month
- •significant change in diet within the last 1 month
- •current use of aspirin
- •allergy to adhesive
- •planned MRI, XR, or CT during the 2-week study period
研究组 & 干预措施
Diabetic with Knee Osteoarthritis
HbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1
干预措施: 40 mg Triamcinolone acetonide (Drug)
Pre-diabetic with Knee Osteoarthritis
HbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1
干预措施: 40 mg Triamcinolone acetonide (Drug)
Non-diabetic with Knee Osteoarthritis
HbA1c < 5.6% in the 3 months prior to Visit 1
干预措施: 40 mg Triamcinolone acetonide (Drug)
结局指标
主要结局
Post-injection glucose levels
时间窗: 1 week
Blood glucose levels after injection of steroid to the knee
次要结局
- KOOS Knee survey(2 weeks)
- Post-injection adverse events(1 week)
研究者
Reed Williams
Assistant Professor
University of Texas Southwestern Medical Center