Obesity Clinical Trial
Official title:
Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team
This is a pilot translational study aiming to compare the effects of a multi-component care
program with personalized drug regimen augmented by behavioural therapy with psychological
support and peer influence, led by a diabetes specialist team on metabolic control,
psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus
usual care.
The study hypothesis is to evaluate a novel individualized, multicomponent care program to
optimize glycemic control in difficult-to-treat type 2 diabetic patients.
Diabetic patients are at high risk for co-morbidities which are closely related to disease
duration and coexisting cardiovascular risk factors and complications. Data has shown that
the following 3 groups of diabetic patients are at extremely high risk for future events:
1. Obese type 2 diabetic patients: Weight control is a major therapeutic challenge which
often requires cognitive-psychological-behavioral therapy (CBT) in addition to
pharmacological and surgical interventions. After long disease duration, often
characterized by the presence of complications, many obese diabetic patients need
insulin to control glycemia which put them at risk of further weight gain which sets up
a vicious cycle.
2. Young type 2 diabetic patients: In both Pima Indian and Caucasian type 2 diabetic
patients, young age of onset substantially increased risk of cardiovascular and renal
complications, mainly due to long disease duration. Furthermore, these patients often
default follow up or are non-compliant due to competing priorities and lack of
symptoms. These young patients also have marked phenotypic heterogeneity characterised
by insulin insufficiency and/or obesity with strong family history.
3. Diabetic patients with established cardiovascular-renal complications. In a series of
analyses, Chinese type 2 diabetic patients with established cardiovascular and kidney
disease had 38% event rates including all-cause death and cardiovascular-renal
complications including peripheral vascular disease (PVD) over 5 years.
These 3 groups of patients are difficult to treat with many unmet needs requiring complex
treatment regimens, intensive counselling and emotional support.
In a series of studies, the investigators have confirmed the marked benefits of using a team
approach to deliver structured care with particular emphasis on continuation of care and
periodic reminders on clinical outcomes. Preliminary analysis from our peer support program
also demonstrated the benefits of utilizing organized and visual information to communicate
personalized risks and targets, further augmented by peer support, to improve risk factor
control in type 2 diabetic patients.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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