None listed
Conditions
Brief summary
The study comprises a randomised trial of intensive “wrap around” management versus standard guideline-based care. Sixty (60) patients with type 2 diabetes and morbid obesity (BMI = 35) will be enrolled. Patients will attend on average nine (9) scheduled study visits over the course of the study. Those found to be eligible after the baseline assessments will be randomised to receive a “wrap around” regimen comprising intensive psychological assessment/counselling, cultural support, intensive dietetic assessment/counselling and an exercise programme or standard guideline-based care in a 1:1 ratio. All participants (i.e. intensive management and standard care) will undergo a bariatric surgery procedure 6-months after randomisation. The total duration of follow-up is 18 months.
Interventions
Intensive “wrap around” regimen comprising intensive psychological assessment/counselling, cultural support, intensive dietetic assessment/counselling and an exercise programme. The duration of this intervention is 6 months pre-operatively and 12 months post-operatively. The exact nature of the regimen will be tailored to the participant on a case by case basis.
Sponsors
Middlemore Clinical Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes Morbid Obesity - BMI >35
Exclusion criteria
Diabetic nephropathy. A significant malabsorptive or gastrointestinal disorder.
Outcome results
None listed