Biochemical Study of Metabolic Regulation and Extraction of Mitochondrial Biomarkers in Type 1 Diabetes Mellitus in Thi-Qar Governorate, Iraq
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Adenosine Triphosphate (ATP) Concentration
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of low-level light therapy on cellular energy and oxidative stress in healthy adults and patients with Type 1 diabetes. The main questions it aims to answer are:
Does light therapy change adenosine triphosphate (ATP) levels and cytochrome c oxidase activity in blood cells? How does the intervention affect oxidative stress markers, specifically glutathione and malondialdehyde concentrations? Researchers will compare blood samples collected before the light therapy to those collected afterward to see if the intervention alters mitochondrial function. Researchers will also compare the responses of healthy volunteers to those of diabetic patients.
Participants will:
Provide a baseline blood sample. Receive red and near-infrared light exposure (660 nm and 850 nm) on their arms for 10 to 20 minutes using a therapy pad.
Provide a final blood sample immediately after the light exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12 to 40 years.
- •Confirmed diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association criteria (patient group).
- •Insulin dependence (patient group).
- •Low serum C-peptide levels (patient group).
- •Fasting plasma glucose concentration <100 mg/dL (healthy control group).
- •Glycated haemoglobin (HbA1c) <5.7% (healthy control group).
排除标准
- •Diabetic ketoacidosis within the preceding month.
- •High-sensitivity C-reactive protein (hs-CRP) >10 mg/L or active infection.
- •Renal insufficiency.
- •Liver disease.
- •Pregnancy.
- •Use of antioxidant supplements, vitamin C, or vitamin E within the preceding month.
- •Autoimmune diseases other than Type 1 Diabetes Mellitus.
- •Haematological disorders.
研究组 & 干预措施
Photobiomodulation Intervention
Researchers apply the photobiomodulation device to the arm of every enrolled participant, encompassing both the healthy volunteers and the patients diagnosed with Type 1 diabetes, for a strictly timed session lasting between 10 and 20 minutes.
干预措施: Red and Near-Infrared Light Therapy Pad (Device)
结局指标
主要结局
Change in Adenosine Triphosphate (ATP) Concentration
时间窗: Baseline and immediately after the 10-to-20-minute light therapy session
Researchers measure ATP levels in blood cells using a specific assay kit to evaluate cellular energy production.
Change in Cytochrome c Oxidase Activity
时间窗: Baseline and immediately after the 10-to-20-minute light therapy session
Researchers assess the specific activity of cytochrome c oxidase in blood samples via a biochemical assay to determine mitochondrial function.
次要结局
- Change in Malondialdehyde (MDA) Levels(Baseline and immediately after the 10-to-20-minute light therapy session)
- Change in Lactate and Pyruvate Concentrations(Baseline and immediately after the 10 to 20-minute light therapy session)
- Change in Glutathione (GSH) Levels(Baseline and immediately after the 10-to-20-minute light therapy session)
- Change in Blood Glucose Levels(Baseline and immediately after the 10-to-20-minute light therapy session)
研究者
Joudi Shaker
MSc Researcher
University of Thi-Qar