Effect of Acute Exercise on Biochemical Parameters in Normal-Weight and Overweight/Obese Adolescent.

NCT07103889 | Completed DMC

• 1 other identifier: ACUTE-EXER-OBESE-2025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obese Adolescents; Overweight

Keywords

Adolescent; Maximal Exercise; Blood Biomarkers; Liver Enzymes; Lipid Profile; Renal Function; obesity; overweight; Normal-weight

Outcome Measures

Primary Outcomes (32)

• Concentration of Blood Glucose (mg/dL)

  Blood glucose levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• iron

  Serum iron concentration will be measured using a colorimetric assay in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Total Cholesterol (mg/dL)

  Total cholesterol will be assessed using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of HDL Cholesterol (mg/dL)

  HDL cholesterol will be analyzed using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Triglycerides (mg/dL)

  Triglyceride levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Calculated LDL Cholesterol (mg/dL)

  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)

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of C-Reactive Protein (CRP) (mg/L)

  CRP levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Erythrocyte Sedimentation Rate (ESR) (mm/hr)

  ESR will be determined using standard laboratory methods in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Aspartate Aminotransferase (AST) (U/L)

  AST levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Alanine Aminotransferase (ALT) (U/L)

  ALT levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Lactate Dehydrogenase (LDH) (U/L)

  LDH levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Creatine Kinase (CK) (U/L)

  CK levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Creatinine (mg/dL)

  Creatinine levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Urea (mg/dL)

  Urea levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Concentration of Serum Uric Acid (mg/dL)

  Serum concentrations of uric acid will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Glomerular Filtration Rate

  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).

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• White Blood Cell Count (WBC) (10³/µL)

  WBC will be measured using standard hematology analyzers in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Red Blood Cell Count (RBC) (10³/µL)

  RBC will be measured using standard hematology analyzers in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Hemoglobin Concentration (Hb) (g/dL)

  Hb concentration will be measured using standard hematology analyzers in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Hematocrit (Hct) (%)

  Hematocrit will be measured using standard hematology analyzers in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Platelet Count (10³/µL)

  Platelet count will be measured using standard hematology analyzers in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Mean Corpuscular Hemoglobin Content (MCH) (pg)

  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.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Mean Hemoglobin Concentration (MCHC) (g/dL)

  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.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Mean Corpuscular Volume (MCV) (fL)

  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

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Plasma volume variations

  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.

  Plasma volume variations (PVV) was calculated Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Sodium Concentration (mmol/L)

  Serum sodium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Potassium Concentration (mmol/L)

  Serum potassium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Chloride Concentration (mmol/L)

  Serum chloride levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Calcium Concentration (mmol/L)

  Serum calcium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Phosphorus Concentration (mmol/L)

  Serum phosphorus levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Magnesium Concentration (mg/dL)

  Serum magnesium concentration will be determined using a spectrophotometric colorimetric method in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

• Serum Iron Concentration (µg/dL)

  Serum iron concentration will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

  At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

Study Arms (2)

Normal-weight adolescent girls

EXPERIMENTAL

Body mass index (BMI) between the 5th and \<85th percentile for age.

Behavioral: Spartacus Test

Overweight/obese adolescent

EXPERIMENTAL

BMI ≥ 85th percentile for age.

Behavioral: Spartacus Test

Interventions

Spartacus Test BEHAVIORAL

The Spartacus test was conducted on a 750 m (75 × 10 m) rectangular course marked with cones at regular intervals to indicate different speeds (from 7 to 18 km/h). Each participant began running at 7 km/h, with speed increasing by 1 km/h every three minutes.During the 3-minute intervals (for each speed stage), participants had 15 seconds to reach the corresponding marker, followed by 15 seconds of rest. Participants had to adjust their running pace to reach the target cone in synchrony with an audio signal. The test ended when a participant failed to reach the next cone within the given time. This test is validated for assessing maximal aerobic capacity (MAS) in obese adolescents. During the Spartacus test, maximal heart rate (HRmax) was recorded using a heart rate monitor (S810; Polar, Kempele, Finland).

Normal-weight adolescent girls; Overweight/obese adolescent

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• High Institute of Sports and Physical Education of Kef: lead

Study Sites (1)

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wissal abassi, Dr

  Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 5, 2025
• Study Start: August 10, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-07

Locations

TU (1)