Status:
UNKNOWN
A Multi-site, Individually Randomized, Controlled Translation Trial of Integrated and Comprehensive Care Strategies to Reduce Cardiovascular Disease (CVD) Risk Among 1,120 Type 2 Diabetes Mellitus(T2DM) Patients in South Asia
Lead Sponsor:
Public Health Foundation of India
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
United Health Group, USA
Conditions:
Type 2 Diabetes Mellitus
Hypertension
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally and Asian Indians will account for between 40-60% of the global CVD burden within the next 10-15 years. Risk...
Eligibility Criteria
Inclusion
- Age 35 years and older
- Confirmed diagnosis of diabetes based on documented evidence from oral glucose tolerance test or two venous fasting blood sugar levels or known diabetes patient on medication or insulin
- Poor glycemic control (as evidenced by HbA1c \>=8.0%) and one or both of: dyslipidemia \[Low density Lipoprotein (LDL) \>=130 mg/dl\] or systolic hypertension \[Systolic Blood Pressure (SBP) \>=140 mmHg\], irrespective of lipid- or BP-lowering medication use, respectively
- Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigator's assessment the patient is likely to follow-up regularly as required by the protocol.
- Willingness to consent to randomization.
Exclusion
- Individuals will be excluded from participation if any of the following are present during screening:
- Known type 1 diabetes mellitus
- Diabetes secondary to chronic pancreatitis
- Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
- Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as evidenced by HbA1c \< 7.0%, SBP \< 130 mmHg, LDL-cholesterol \< 100 mg/dl \[LDL-cholesterol \< 70 mg/dl with history of CVD event\]) obtained from screening within a period not exceeding 28 days (4 weeks) prior to randomization
- Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months
- Current symptomatic Congestive Heart Failure (CHF) or New York Heart Association (NYHA) Class 3 or 4 effort intolerance
- Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy \[dialysis or transplant\])
- Transaminase \>3 times upper limit of normal OR active liver disease within past 2 years
- Malignancy or life-threatening disease with death probable in 4 years
- Any current medication (e.g. long-term steroids, protease inhibitors) that, in the opinion of the site investigator, would interfere with participant's diabetic status and follow-up
- Any condition or circumstance that is unrelated to diabetes progression, that in the opinion of the site investigator would interfere with the participant's diabetic status and follow-up: including (but not limited to) other endocrinopathy \[adrenal, pituitary\], Tuberculosis (TB) patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, Body Mass index (BMI) \>= 45 kg/m2
- On an investigational drug in the last 3 months
- Currently participating in a clinical trial
- No fixed address or contact details
- Plans to move in the next 3 years
- A member of the participant's household is currently in the trial
- Inability or unwillingness of individual or legal guardian /representative to give written informed consent
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
1120 Patients enrolled
Trial Details
Trial ID
NCT01212328
Start Date
October 1 2010
End Date
June 1 2014
Last Update
September 5 2011
Active Locations (10)
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1
Bangalore Endocrinology and Diabetes Research Centre,
#35, 5th Cross,Malleswaram Circle,, Bangalore, Karnataka, India, 560 003
2
St. John's Medical College & Hospital,
Sarjapur Road, Koramangala,, Bangalore, India, 560 034
3
Diabetes Research Centre & MV Hospital for Diabetes,
No 4 West Madha Church Street, Royapuram, Chennai, India, 600 013
4
Endocrine Division, Department of Medicine, Goa Medical College,
Bambolim, Goa, India, 403202