NCT01610778已完成不适用
A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Fasting glucose level
研究概览
简要总结
This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients on medication
- •HbA1c ≤ 9.0% (as JDS values, which is equivalent to HbA1c ≤ 9.4% as NGSP values)
- •On stable treatment of diabetes for at least the last 3 months
- •With permission to attend the clinical trial from the primary doctor
排除标准
- •On insulin therapy
- •BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
- •History of porphyria, hemochromatosis, or viral hepatitis
- •Pregnant or nursing a child
- •Heart disease
- •Renal or hepatic dysfunction
- •Participation in any clinical trial within 90 days of the commencement of the trial
结局指标
主要结局
Fasting glucose level
时间窗: Every 4 weeks (Overall 36 weeks)
HbA1c level
时间窗: Every 4 weeks (Overall 36 weeks)
Glycoalbumin level
时间窗: Every 4 weeks (Overall 36 weeks)
次要结局
- Fasting insulin level(Every 4 weeks (Overall 36 weeks))
- 1,5-AG level(Every 4 weeks (Overall 36 weeks))
- Serum C-peptide level(Every 4 weeks (Overall 36 weeks))
- HOMA-R(Every 4 weeks (Overall 36 weeks))
研究者
Fumiko Higashikawa
Associate professor
Hiroshima University
研究点 (2)
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