ISRCTN17447843已完成不适用
Effect of insulin therapy and dietary adjustments on performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized, cross-over, double-blinded, controlled trial
Asociación Nacional Pro Estudio de la Diabetes, Endocrinología y Metabolismo0 个研究点目标入组 16 人开始时间: 2017年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18 years and over
- •2. More than two years of established T1D diagnosis
- •3. Stable insulin regimen in the past 6 months indexed by a less than 20% of changes in total insulin daily dose
- •4. HbA1c less than 9.0%
- •5. Weekly physical activity of 90 min or more
- •6. Participation in recreational or competitive soccer-related activities, at least four times per month
- •7. Able to provide informed consent
排除标准
- •1. Any treatment regimen different from continuous subcutaneous insulin infusion or multiple daily insulin injections
- •2. Any use of medications (other than insulin) known to affect glycemic control including oral or parenteral steroids (except for inhaled steroids), metformin, SGLT2 inhibitors, GLP.1 agonists, thiazolidinediones, sulfonylureas, DPP-4 inhibitors, or any other oral antidiabetic therapy
- •3. Detectable C-peptide in serum
- •4. Cognitive impairment comprising any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor and cognitive testing, not including hypoglycemia unawareness
- •5. Chronic kidney disease (glomerular filtration rate less than 90 ml·min-1)
- •6. Chronic liver failure (Child-Pugh B or C)
- •7. Advanced diabetic retinopathy
- •8. Pregnancy
- •9. Color blindness
研究者
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