Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
Study hypothesis
The weight reduction with the change of fat distribution influence on the adipokines and metabolic indices.
Ethics approval
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).
Study design
A prospective intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Obesity
Intervention
All 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 type
Drug
Phase
Not Specified
Drug names
Sibutramine
Primary outcome measures
The 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 measures
The 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 trial start date
06/09/2006
Overall trial end date
31/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
52
Participant exclusion criteria
1. 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
Recruitment start date
06/09/2006
Recruitment end date
31/05/2007
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Family Medicine
Seoul
135-270
Korea, South
Sponsor information
Organisation
Yonsei University College of Medicine (South Korea)
Sponsor details
250 Sungsan-Ro
Seodaemoon-gu
Seoul
120-752
Korea
South
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Yonsei University College of Medicine (South Korea) - faculty research grant (2006)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary