Assessment of Biochemical, Metabolic, Inflammatory, and Hematological Parameters Following Acute Exercise in Normal-Weight and Overweight/Obese Adolescent Girls.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Erythrocyte Sedimentation Rate (ESR) (mm/hr)
研究概览
简要总结
The goal of this interventional clinical trial is to compare the acute physiological and biochemical responses to maximal physical exercise (Spartacus test). in two groups of adolescent girls: in normal-weight and overweight/obese adolescent. The main question it aims to answer:
- Does Spartacus test significantly alter glucose metabolism and lipid profile in normal-weight and overweight/obese adolescent?
- How do inflammatory markers such as C-Reactive Protein [CRP], Erythrocyte Sedimentation Rate [ESR], respond immediately after and 30 minutes following maximal effort?
- Are there significant changes in liver enzymes (Aspartate Aminotransferase [AST], Alanine Aminotransferase [ALT]), muscle damage indicators (creatine kinase [CK], Lactate Dehydrogenase [LDH]), and electrolyte balance post-exercise? Participants will undergo a baseline blood draw before performing the Spartacus test , a progressive maximal exercise test. Blood samples will then be collected immediately after the test and again 30 minutes post-exercise to evaluate changes in: Glucose metabolism (fasting glucose), Lipid profile (total cholesterol, High-Density Lipoprotein [HDL], Low-Density Lipoprotein [LDL], triglycerides), Liver and muscle enzymes (Aspartate Aminotransferase [AST], Alanine Aminotransferase [ALT], Creatine kinase [CK], Lactate Dehydrogenase [LDH]), Renal function markers (creatinine, urea), Inflammatory markers (C-Reactive Protein [CRP], Erythrocyte Sedimentation Rate [ESR]), Hematological profile (complete blood count: White Blood Cells [WBC], Red Blood Cells [RBC], Hemoglobin [Hb], Hematocrit [Hct], platelets), Electrolytes (sodium, potassium, chloride), Uric acid, calcium, phosphorus, magnesium, iron.
详细描述
This is an interventional clinical trial designed to evaluate the acute physiological and biochemical responses to maximal physical exercise (Spartacus test) in normal-weight and overweight/obese adolescent. The study aims to investigate how a single session Spartacus test affects key metabolic, inflammatory, hepatic, muscular, renal, and hematological parameters.
Participants will be divided into two groups:
Group 1: Normal-weight adolescent girls Adolescent girls with a body mass index (BMI) between the 5th and <85th percentile for age.
Group 2: Overweight/obese adolescent girls Adolescent girls with a BMI ≥ 85th percentile for age. The protocol involves running on a simulated rectangular course (750 m²), with increasing speed every 3 minutes (starting at 7 km/h and increasing by 1 km/h each stage). Participants must reach a marked cone corresponding to the new speed within 15 seconds, followed by a 15-second rest period before the next stage begins. The test continues until voluntary exhaustion or inability to maintain the required pace.
Blood samples will be collected at three time points:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 14-18 years
- •BMI between the 5th and <85th percentile for age (normal-weight group), or BMI ≥ 85th percentile for age (overweight/obese group)
- •No chronic illness or contraindication to exercise
- •No regular medication use
- •Written informed consent from participant and parent/legal guardian
排除标准
- •Presence of chronic diseases (diabetes, thyroid disorders, etc.)
- •Musculoskeletal or cardiovascular contraindications to maximal exercise
- •Pregnancy
- •Recent infection or inflammation
- •Use of anti-inflammatory or hormonal medications
研究组 & 干预措施
Normal-weight adolescent girls
Body mass index (BMI) between the 5th and <85th percentile for age.
干预措施: Spartacus Test (Behavioral)
Overweight/obese adolescent
BMI ≥ 85th percentile for age.
干预措施: Spartacus Test (Behavioral)
结局指标
主要结局
Erythrocyte Sedimentation Rate (ESR) (mm/hr)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
ESR will be determined using standard laboratory methods in a certified clinical laboratory.
Hematocrit (Hct) (%)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Hematocrit will be measured using standard hematology analyzers in a certified clinical laboratory.
Serum Chloride Concentration (mmol/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum chloride levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Serum Iron Concentration (µg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum iron concentration will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Blood Glucose (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Blood glucose levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Serum Potassium Concentration (mmol/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum potassium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Serum Calcium Concentration (mmol/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum calcium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
iron
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum iron concentration will be measured using a colorimetric assay in a certified clinical laboratory.
Concentration of Total Cholesterol (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Total cholesterol will be assessed using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of HDL Cholesterol (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
HDL cholesterol will be analyzed using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Aspartate Aminotransferase (AST) (U/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
AST levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Creatinine (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Creatinine levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Triglycerides (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Triglyceride levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Calculated LDL Cholesterol (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
LDL cholesterol will be estimated using the Friedewald formula based on total cholesterol, HDL cholesterol, and triglycerides measured via enzymatic colorimetric assays in a certified clinical laboratory. LDL-C (mg/dL)=Cholesterol total-HDL Cholesterol-( Triglycerides /5)
Concentration of C-Reactive Protein (CRP) (mg/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
CRP levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Serum Uric Acid (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum concentrations of uric acid will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Platelet Count (10³/µL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Platelet count will be measured using standard hematology analyzers in a certified clinical laboratory.
Mean Corpuscular Volume (MCV) (fL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Blood levels of mean corpuscular volume will be measured from a 5 ml blood sample and analyzed using a multichannel automated hematology analyzer in a certified clinical laboratory
Concentration of Alanine Aminotransferase (ALT) (U/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
ALT levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Lactate Dehydrogenase (LDH) (U/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
LDH levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Creatine Kinase (CK) (U/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
CK levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Concentration of Urea (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Urea levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Hemoglobin Concentration (Hb) (g/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Hb concentration will be measured using standard hematology analyzers in a certified clinical laboratory.
Mean Hemoglobin Concentration (MCHC) (g/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Blood levels of mean hemoglobin concentration will be measured from a 5 ml blood sample and analyzed using a multichannel automated hematology analyzer in a certified clinical laboratory.
Plasma volume variations
时间窗: Plasma volume variations (PVV) was calculated Immediately after Spartacus, and 30 minutes post-Spartacus.
Plasma volume variations (PVV) was calculated based on measured hematocrit (Ht) and hemoglobin (Hb) valuesaccording to the method developed by Costill and Fink (1974). %PVV=100 ×\[(HbA/HbB) ×(100 - HtB) / (100 - HtA)\] - 1, where 0 is the value measured before exercise and 1 is the value measured after exercise.
Serum Sodium Concentration (mmol/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum sodium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Serum Phosphorus Concentration (mmol/L)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum phosphorus levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.
Serum Magnesium Concentration (mg/dL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Serum magnesium concentration will be determined using a spectrophotometric colorimetric method in a certified clinical laboratory.
Glomerular Filtration Rate
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
The glomerular Filtration Rate (GFR) has been computed using the Cockcroft formula, as follows: GFR (mL/min) = \[(140 - age) × weight ×0.85\]/( Serum Creatinine× 72).
White Blood Cell Count (WBC) (10³/µL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
WBC will be measured using standard hematology analyzers in a certified clinical laboratory.
Red Blood Cell Count (RBC) (10³/µL)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
RBC will be measured using standard hematology analyzers in a certified clinical laboratory.
Mean Corpuscular Hemoglobin Content (MCH) (pg)
时间窗: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.
Blood levels of mean corpuscular hemoglobin content will be measured from a 5 ml blood sample and analyzed using a multichannel automated hematology analyzer in a certified clinical laboratory.
次要结局
未报告次要终点
研究者
Wissal Abassi
Principal Investigator
High Institute of Sports and Physical Education of Kef