The differential effects of visceral fat reduction compared with subcutaneous fat reduction on parameters of the metabolic indices and adipocytokines

ISRCTN ISRCTN79667806
DOI https://doi.org/10.1186/ISRCTN79667806
Secondary identifying numbers 1
Submission date
18/09/2007
Registration date
10/10/2007
Last edited
10/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ji-Won Lee
Scientific

Department of Family Medicine
Yonsei University College of Medicine
Yongdong Severance Hospital
Kangnam
P.O. Box 1217
Seoul
135-270
Korea, South

Study information

Study designA prospective intervention study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesThe weight reduction with the change of fat distribution influence on the adipokines and metabolic indices.
Ethics approval(s)Ethics approval received from the Institutional Review Board of Yondong Severance Hospital, Yonsei University College of Medicine (South Korea) on the 6th September 2006 (ref: 3-2006-0044).
Health condition(s) or problem(s) studiedObesity
InterventionAll patients received all three interventions for 16 weeks:
1. The subjects visited an obesity clinic twice per month and restricted their caloric intake to less than their usual intake by 600 kcal/day
2. All patients were encouraged to achieve the goal of five hours of aerobic exercise (physical activity of moderate intensity, such as brisk walking, light jogging or stationary ergometer usage) per week
3. They were also administered 10 - 15 mg of sibutramine (in the morning)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sibutramine
Primary outcome measureThe changes of body fat distribution and adipocytokines, determined by computed tomography scan and measured both before and 16 weeks after the weight reduction program.
Secondary outcome measuresThe relationship of body fat distribution and adipocytokines, determined by computed tomography scan and measured both before and 16 weeks after the weight reduction program.
Overall study start date06/09/2006
Completion date31/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants52
Key inclusion criteria1. Apparently healthy, either sex, aged 18 - 60 years
2. Non-smokers
3. Low alcohol consumers
4. Overweight or obese with an average Body Mass Index (BMI) of 23 kg/m^2 or greater
Key exclusion criteria1. A past history of cardiovascular disease
2. Diabetes
3. Moderate to severe hypertension (resting blood pressure greater than 170/100 mmHg)
4. Renal impairment (serum creatinine greater than 120 µmol/L) or overt proteinuria
5. Obesity caused by an endocrine disorder
6. Psychiatric disorders
7. Current pregnancy or breast-feeding
8. A body weight fluctuation of more than 5 kg in the previous six months
9. Taking any kind of medication
Date of first enrolment06/09/2006
Date of final enrolment31/05/2007

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Family Medicine
Seoul
135-270
Korea, South

Sponsor information

Yonsei University College of Medicine (South Korea)
University/education

250 Sungsan-Ro
Seodaemoon-gu
Seoul
120-752
Korea, South

Website http://medicine.yonsei.ac.kr/en/index.asp
ROR logo "ROR" https://ror.org/01wjejq96

Funders

Funder type

University/education

Yonsei University College of Medicine (South Korea) - faculty research grant (2006)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan