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 |
| Protocol serial number | 1 |
| Sponsor | Yonsei University College of Medicine (South Korea) |
| Funder | Yonsei University College of Medicine (South Korea) - faculty research grant (2006) |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | A prospective intervention study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The 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) studied | 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 / device / biological / vaccine name(s) | Sibutramine |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 52 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/09/2006 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Family Medicine
Seoul
135-270
Korea, South
135-270
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
