Clinical trial NCT01690208: Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by a Diabetes Specialist Team
Official title: Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Obesity
Keywords: Diabetes
Structure Care
Lead sponsor: Asia Diabetes Foundation
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Obese type 2 diabetic patients: body mass index (BMI) \>27 kg/m2 and/or waist circumference (WC) \>80cm in women and \>90cm in men and HbA1c \>8% aged 18-70 years
* Young type 2 diabetic patients: age 35-55 years and HbA1c \>8%
* Diabetic patients with established cardiovascular-renal complications: HbA1c \>8% and known cardiovascular and renal complications with chronic kidney disease (CKD) stage 3-4 (i.e. estimated glomerular filtration rate \<60 to \>15 ml/min/ per 1.73m2) aged 18-70 years.

Exclusion Criteria:

* Type 1 diabetes
* Active malignant disease (Patients with malignant disease who have been disease-free for at least 5 years are eligible)
* Life expectancy less than 12 months
* Any medical illness or condition as judged by the investigators as ineligible to participate the study.

Primary outcomes:
measure: Glycemic control as measured by HbA1c compared to baseline
timeFrame: 36 months
Secondary outcomes:
measure: Control of BP compared to baseline.
timeFrame: 36 months
measure: Control of low density lipoprotein (LDL) cholesterol compared to baseline.
timeFrame: 36 months
measure: Control of BMI and other obesity indices compared to baseline
timeFrame: 36 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: DMEC Centre, Prince of Wales Hospital
Study officials:
affiliation: Asia Diabetes Foundation
name: Juliana Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: