Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls

NCT04447391 | Completed

• 1 other identifier: 04-2015-015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.

Conditions

Ghrelin

Outcome Measures

Primary Outcomes (3)

• body fat percent

  Changes in body fat percent during 12 weeks

  Change from baseline body fat percent at 12 weeks

• acylated ghrelin

  Changes in concentrations of acylated ghrelin during 12 weeks

  Change from concentrations of baseline acylated ghrelin at 12 weeks

• desacylated ghrelin

  Changes in concentrations of desacylated ghrelin during 12 weeks

  Change from concentrations of baseline desacylated ghrelin at 12 weeks

Secondary Outcomes (1)

• ghrelin O acyl transferase

  Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

Exercise group who performed a combined exercise and 300 kcal/day deficit diet during 12 weeks.

Other: Combined exercise program

Control group

PLACEBO COMPARATOR

Control group who performed 300 kcal/day deficit diet during 12 weeks.

Other: Control

Interventions

Combined exercise program OTHER

Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet

Exercise group

Control OTHER

300 kcal deficit diet only

Control group

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• girls between 16 and 18 years
• being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for Korean children aged 2-18 years.
• After consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school.

You may not qualify if:

• participation in any weight-management programme in the past 6 months
• engagement in other exercise programs except for regular physical education at school
• smoking
• amenorrhea for consecutive 2 months or more
• being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments
• taking any medication or supplements for weight control

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: September 10, 2015
• Primary Completion: December 30, 2015
• Study Completion: December 31, 2015
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)