Obesity Clinical Trial
— EMERALDOfficial 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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | DMEC Centre, Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Asia Diabetes Foundation |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycemic control as measured by HbA1c compared to baseline | Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year. | 36 months | No |
Secondary | Control of BP compared to baseline. | Outcome measures will be assessed in all 600 patients in both groups at 1 year and 3 year. | 36 months | No |
Secondary | Control of low density lipoprotein (LDL) cholesterol compared to baseline. | Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year. | 36 months | No |
Secondary | Control of BMI and other obesity indices compared to baseline | Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year. | 36 months | No |
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