Comparative Study of Intragastric Balloon and Pharmacotherapy for Non-Morbid Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355979
Recruitment Status : Unknown
Verified July 2006 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : July 25, 2006
Last Update Posted : October 18, 2006
Information provided by:
Chinese University of Hong Kong

Brief Summary:
To evaluate and compare the effectiveness of intragastric balloon and Sibutramine (Reductil®) in the treating of non-morbid obese in a randomized controlled manner

Condition or disease Intervention/treatment Phase
Obesity Device: intragastric balloon Phase 3

Detailed Description:

Obesity is a chronic devastating disease and is becoming a major health and socioeconomic issue worldwide. Obesity significantly exacerbates many other chronic illnesses and increases mortality and morbidities of patients.1-2 Although the situation in Asians is less apparent and critical than in Caucasians, the problem is emerging rapidly. In Hong Kong, there are approximately 29% of adults classified as obese according WHO Asian criteria 3 and there is an increasing demand for obesity treatment in Asia-Pacific region.4 The first practical aim of treating obesity nowadays should focus on a sustained body weight loss of 10-15% to alleviate obesity-related illnesses such as hypertension, diabetes and obstructive sleep apnoea.

Intragastric balloon (IGB) was initially developed from observing the effects naturally caused by bezoars and the first documentation in human use was reported in 1982.5 However, earlier balloon designs were plagued by high balloon failure rates and serious complications.6-8 Since then, balloon design has undergone several major modifications in terms of material, shape and filling substances. The newer design of balloon (Bioenterics® Intragastric Balloon (BIB®) system) was introduced in 1999 9 and has undergone extensive evaluation recently in Europe with promising results.10-11 It is placed inside the stomach endoscopically for a maximum of 180 days to decrease stomach capacity and gastric emptying. It facilitates patient’s compliance to the restricted diet prescribed and together with increasing level of physical activities, most reports have shown moderate body weight loss of 15 % or more.10--12 More importantly, the newer design balloon (BIB) is more reliable and predictable. The reported premature balloon rupture and serious complication is rare if it is removed within the recommended period and followed up carefully by a dedicated obesity team in a multidisciplinary approach.10-12 Sibutramine (Reductil®) is a serotonin and noradrenaline reuptake inhibitor and is one of the FDA approved weight reduction pharmacotherapy. Its central action on neurotransmitters causes an enhancement of satiety (fullness) after eating. In addition, it causes sympathetically mediated thermogenesis, which prevent the reduction in basal metabolic rate (BMR) normally seen in individual on restricted diet and thereby effectively increases resting energy consumption and promotes weight loss. A combination of sibutramine and lifestyle modification program has been shown up to 10 % of body weight loss while intragastric balloon and sibutramine are the two most commonly used non-surgical method for weight reduction. There is lack of randomized controlled trial in comparing these two methods in the treatment of obesity. Since these two types of therapy are most efficient in non-morbid obese patients, we are designing a trial to compare the effect of the two different weight reduction therapies in this group of patients in a double-blind manner.

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Trial of Intragastric Balloon and Pharmacotherapy for Non-Morbid Obesity
Study Start Date : March 2006
Study Completion Date : March 2008

Primary Outcome Measures :
  1. Body weight loss in terms of % of body weight and BMI loss at 6-month and 1 year.

Secondary Outcome Measures :
  1. Regain of weight after treatment, complications and compliance of treatment, change of satiety level and calorie intake during and after treatment, quality of life, change in hormonal profile and patient's satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age 18-60
  2. BMI 27-35
  3. Agree to undergo invasive weight reduction therapy and intensive follow-up
  4. No history of weight reduction for >5% of BW for the past 6 months

Exclusion Criteria:

  1. Coronary heart disease
  2. Un-controlled hypertension (160/90 mmHg)
  3. unstable cardiovascular disease
  4. unstable cerebrovascular disease
  5. Renal disease
  6. Liver disease

9) Diabetes Mellitus 10) Eating disorder 11) Psychiatric illness 12) Pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00355979

Contact: Wilfred LM Mui, FRCS 26322627

China, Hong Kong
The Chinese University of Hong Kong, Department of Surgery Recruiting
Hong Kong, Hong Kong, China
Contact: Wilfred LM Mui, FRCS    26322627   
Principal Investigator: Wilfred LM Mui, FRCS         
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Wilfred LM Mui, FRCS The Chinese University of Hong Kong, Hong Kong ,China Identifier: NCT00355979     History of Changes
Other Study ID Numbers: CRE-2006.084
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: July 2006

Keywords provided by Chinese University of Hong Kong:
Obesity, intragastric balloon, Pharmacotherapy

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms