None listed
Conditions
Interventions
Non-surgical intervention with intragastric balloon inserted into the stomach under endoscopic visualisation for a total of 6 months, as an adjunct to a 12 month behavioural management programme of supervised diet and exercise (A balanced diet high in whole grains, fruit and vegetables and with reduced fat intake. A moderate exercise regimen of at least 30 minutes/day will be instituted. This programme will be individualised and assessed each month by the study dietitian and the study exercise p
Non-surgical intervention with intragastric balloon inserted into the stomach under endoscopic visualisation for a total of 6 months, as an adjunct to a 12 month behavioural management programme of supervised diet and exercise (A balanced diet high in whole grains, fruit and vegetables and with reduced fat intake. A moderate exercise regimen of at least 30 minutes/day will be instituted. This programme will be individualised and assessed each month by the study dietitian and the study exercise physiologist and will be amended as required)
Sponsors
Allergan Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
(i) Body Mass Index (BMI) between 30 & 40 kg/m2 with metabolic syndrome (ii) Failed attempts to lose weight with supervised weight loss programmes
Exclusion criteria
Specific Gastrointenstinal [GI] diseases/conditions (e.g. inflammatory; bleeding; dysmotility) Prior gastric surgery; type 1 diabetes; untreated thyroid disease, hepatic or moderate to severe renal insufficiency; pregnancy; alcohol or drug dependence; psychiatric disorders; medication affecting weight or appetite
Outcome results
None listed