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Trial record 43 of 228 for:    EDN1

The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.

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ClinicalTrials.gov Identifier: NCT03146026
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Songyoung Park, Pusan National University

Brief Summary:
The purpose of this study was to examine the impact of 12 weeks of combined exercise training (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. Thirty obese adolescent girls participated in this study. The girls were randomly divided into CET group (n=15) and control group (n=15). The CET group performed concurrent resistance training followed by aerobic training at 40-70% of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1, C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after the 12-weeks study.

Condition or disease Intervention/treatment Phase
Obesity, Adolescent Behavioral: Combined Exercise Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effects of a 12- Week Combined Exercise Training Program on Arterial Stiffness, Endothelial Function, Inflammatory Markers and Metabolic Profile in Obese Adolescent Girls: A Pilot Study.
Actual Study Start Date : February 8, 2016
Actual Primary Completion Date : May 2, 2016
Actual Study Completion Date : May 6, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Exercise (CON)
Fifteen obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake was 1921.7 kcal/day.
Experimental: Combined Exercise Training (CET)
Fifteen obese adolescent girls. This arm performed combined exercise training 3 times per a week for 12 weeks. Caloric intake was 1921.7 kcal/day.
Behavioral: Combined Exercise Training
The CET program was performed for 60 minutes with 5 minutes of warm-up and cool-down per day, 3 times a week for 12 weeks. Combined exercise consisted of 20 minutes of various resistant band exercises (Upper body: seated rows, biceps curl, shoulder flexion, elbow flexion, chest press; Lower body: hip flexion, hip extension, calf raise, leg press, squat) and 30 minutes of treadmill walking. The warm-up and cool down consisted of static stretching. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4, and to 60-70% HRR in weeks 9-12. Each training session was fully supervised by the researchers. Every subject wore a heart rate monitor during the whole training session so as to maintain the correct training intensity.




Primary Outcome Measures :
  1. Arterial stiffness [ Time Frame: 12 weeks ]
    Arterial stiffness was measured as measurement of baPWV (m/s).

  2. Endothelin-1 [ Time Frame: 12 weeks ]
    Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.

  3. Insulin resistance [ Time Frame: 12 weeks ]
    Insulin resistance was estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).

  4. Plasma leptin [ Time Frame: 12 weeks ]
    Plasma leptin was determined by ELISA kit

  5. Plasma adiponectin [ Time Frame: 12 weeks ]
    Plasma adiponectin was measured using ELISA kit

  6. Body weight [ Time Frame: 12 weeks ]
    Body weight was measured to nearest 0.1 kg.

  7. Height [ Time Frame: 12 weeks ]
    Height was measured to nearest 1 cm.

  8. Waist circumference [ Time Frame: 12 weeks ]
    Waist circumference was measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tape measure

  9. Body fat [ Time Frame: 12 weeks ]
    Percent body fat (%) was determined using a bioelectrical impedance-meter.

  10. Maximal heart rate [ Time Frame: 12 weeks ]
    Maximal heart rate was obtained at the end of a graded treadmill exercise test performed until volitional exhaustion.

  11. Nitric oxide [ Time Frame: 12 weeks ]
    Nitric oxide generation was measured by Griess assay kit.



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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese with hyperinsulinemia
  • Abdominal obesity
  • Sedentary (no regular exercise training or physical activity)
  • No weight loss diet during last 6 months.

Exclusion Criteria:

  • Hypertension
  • Pregnancy
  • Chronic disease

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Songyoung Park, Principal Investigator, Pusan National University
ClinicalTrials.gov Identifier: NCT03146026     History of Changes
Other Study ID Numbers: PusanNU-2
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms