Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00135

2 Trial Registration Date

2007-09-12

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental Funding

5 Primary Sponsor

N/A

6 Secondary Sponsor

The Orlistat tablets used in this study are supplied by Roche Pharmaceuticals

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Professor Albert Martin Li

ii Address

iii Phone

Department of Paediatrics, Prince of Wales Hospital, Shatin, Hong Kong

iv Email

Tel: 26322982; Fax: 26360020; E-mail: albertmli@cuhk.edu.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Professor Albert Martin Li

ii Address

iii Phone

Department of Paediatrics, Prince of Wales Hospital, Shatin, Hong Kong

iv Email

Tel: 26322982; Fax:26360020; E-mail: albertmli@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Effects of Orlistat with or without Strength training on physical fitness and endothelial function of obese adolescents - a pilot study.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-06-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Obesity

15 Intervention

i Types of intervention

Other

Please specify

Drug and Behaviour

ii Description/ name of Intervention/article

ORLISTAT-Participants in Group A and Group B will be given orlistat (medication to be provided by Roche Pharmaceuticals) 120mg for three times a day with meals. In addition, a multivitamin supplement (5000IU of vitamin A, 400IU of vitamin D, 30IU of vitamin E and 25microgram of vitamin K1) wil be given and to be taken at night. Participants return medication to the research staff at each interview and the regimen adherence can be estimated by pill count. A diary will also be given for completion, this is to encourage compliance with the medication. In addition, side-effects from the medication are recorded. STRENGTH TRAINING PROGRAM- This strength training sessions will be carried out twice a week on non-consecutive days for 12 weeks. At least 10 minutes brisk walking plus stretching of large muscle groups will be performed as a warm up session prior to the strength training session. The strength training program is in circuit style with a pre-set sequence of 12 workout stations. Individually tailored resistance will be marked on the working sheet of each student before the training class and the students will be supervised to perform the exercise with appropriate technique. There will be 5 minutes rest between circuit sets. Free weights will be used to provide the resistance at the workout stations. The resistance will be set at a level that permits at least eight lifts with full range of motion and good form. Quantitatively, the resistance training level will be set at 8-repetition maximum (RM) in most of the workout. 1 repetition maximum (1 RM) is defined as the maximum amount of resistance that can be actively overcome only one time.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

July to September 2007

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Dietary supervision - ALL participants will be individually interviewed by the same dietitian who is blinded to the group allocation. The dietitian will prescribe a nutritionally balanced, hypocaloric diet to each participant and will ask the participant about the complicance with the diet biweekly for the first month, then once per month until the end of the project.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Obese adolescents (aged>12years) from the Obesity & Lipid Disorder clinic will be invited to participate in the study. Inclusion criteria are primary obesity, BMI>95th percentile using local reference. Obese adolescents with underlying metabolic diseases will be excluded.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2007-07-03

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

Endothelial function of the brachial artery at 12 weeks of the program.

24 Secondary Outcome

Assessments of anthropometric measures, body composition, peak oxygen consumption, heart rate variability, endothelial function, clinical laboratory tests (fasting lipids, glucose, insulin, ghrelin, hs-CRP, and vitamin levels), and physical activity level will be carried out for all subjects within 3 weeks before the start of the program, and at 4 months of the program.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-26

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2007-09-12