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Trial History Detail on 2007-09-12

CUHK_CCT00135

2007-09-12

Retrospective

Nil

Departmental Funding

N/A

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

Professor Albert Martin Li

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

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

Professor Albert Martin Li

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

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

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

Nil

Yes

2007-06-08

Obesity

Other

Drug and Behaviour

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.

July to September 2007

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.

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.

Randomized

Historical control

Open label

Parallel

2007-07-03

60

Complete

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

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.

No

2009-11-26


Yes

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