NCT00355979

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 18, 2006

Status Verified

July 1, 2006

First QC Date

July 24, 2006

Last Update Submit

October 17, 2006

Conditions

Obesity

Keywords

Obesity, intragastric balloon, Pharmacotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

intragastric balloonDEVICE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Coronary heart disease
  • Un-controlled hypertension (160/90 mmHg)
  • unstable cardiovascular disease
  • unstable cerebrovascular disease
  • Renal disease
  • Liver disease
  • \) Diabetes Mellitus 10) Eating disorder 11) Psychiatric illness 12) Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong, Department of Surgery

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wilfred LM Mui, FRCS

    The Chinese University of Hong Kong, Hong Kong ,China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilfred LM Mui, FRCS

CONTACT

26322627wilfredmui@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

March 1, 2006

Study Completion

March 1, 2008

Last Updated

October 18, 2006

Record last verified: 2006-07

Locations

CN(1)