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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00355979
First received: July 24, 2006
Last updated: October 17, 2006
Last verified: July 2006
  Purpose

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 Intervention Phase
Obesity
Device: intragastric balloon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Trial of Intragastric Balloon and Pharmacotherapy for Non-Morbid Obesity

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355979

Contacts
Contact: Wilfred LM Mui, FRCS 26322627 wilfredmui@hotmail.com

Locations
China, Hong Kong
The Chinese University of Hong Kong, Department of Surgery Recruiting
Hong Kong, Hong Kong, China
Contact: Wilfred LM Mui, FRCS    26322627    wilfredmui@hotmail.com   
Principal Investigator: Wilfred LM Mui, FRCS         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wilfred LM Mui, FRCS The Chinese University of Hong Kong, Hong Kong ,China
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00355979     History of Changes
Other Study ID Numbers: CRE-2006.084
Study First Received: July 24, 2006
Last Updated: October 17, 2006
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 30, 2014