Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/09/2007
Date assigned
10/10/2007
Last edited
10/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ji-Won Lee

ORCID ID

Contact details

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

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

http://medicine.yonsei.ac.kr/en/index.asp

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

Publication citations

Additional files

Editorial Notes