A multi-site, individually randomized, controlled translation trial of integrated and comprehensive care strategies to reduce CVD risk among 1,120 T2DM patients in South Asia.

Completed

Conditions: Type 2 diabetes mellitus with circulatory complications,

Registration Number: CTRI/2010/091/001185

Lead Sponsor: National Heart Lung and Blood Institute National Institutes for Heath USA

Brief Summary: Background: Cardiovascular diseases 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 factor control and preventive care are effective in reducing CVD events and mortality. The greatest gains in CVD prevention have been seen when early and target-driven interventions address multiple risk factors together. However, achieving control of even individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor, globally. Quality improvement schemes, like the proposed intervention, have shown promise in high-income countries, but are untested in South Asia; a region with a population at extraordinarily high CVD risk. Objective: To test whether a clinic-based case management intervention (consisting of guidelines based treatment, care coordinator assistance and decision support software) to reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is more effective and sustainable compared to existing care. Trial subjects and methods: The study will involve a total of 1120 patients attending 8 established out-patient clinics in South Asia (140 patients at each clinic). Patients enrolled in the trial will be randomly assigned to either the control (existing care) or the intervention group and will be followed up for an average of 30 months. The total trial duration is about 3.5 years, from mid-August 2010 to December 31, 2013. Eligibility criteria for entry into the study include all the following: 1. Age 35 years and older 2. 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 (2006 WHO criteria, 154) 3. Poor glycemic control (as evidenced by HbA1c >= 8.0%) AND one or both of: dyslipidemia (LDL 130 >= mg/dl) or systolic hypertension (SBP >= 140 mmHg), irrespective of lipid or BP lowering medication use, respectively 4. Receiving diabetes care in the same clinic for at least 6 months with at least 2 documented visits at this clinic 5. Willingness to consent to randomization

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1146

Inclusion Criteria

Age 35 years and older 2.
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 3.
Poor glycemic control (as evidenced by HbA1c greater than or equal to 8.0%) AND one or both of: dyslipidemia (LDL greater than or equal to 130 mg/dl) or systolic hypertension (SBP greater than or equal to 140 mmHg), irrespective of lipid- or BP-lowering medication use, respectively 4.
Willingness to consent to randomization Note- The trial has no upper age limit.

Exclusion Criteria

Individuals will be excluded from participation if any of the following are present during screening:1.
Known type 1 diabetes mellitus2.
Diabetes secondary to chronic pancreatitis3.
Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birthcontrol (including natural methods)4.
Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (asevidenced by HbA1c < 7.0%, SBP < 130 mmHg, LDL-cholesterol < 100 mg/dl [LDL-cholesterol < 70mg/dl with history of CVD event]) obtained from screening within a period not exceeding 28 days (4weeks) prior to randomization5.
Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12months6.
Current symptomatic CHF or NYHA Class 3 or 4 effort intolerance7.
Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy [dialysis or transplant])8.
Transaminase >3 times upper limit of normal OR active liver disease within past 2 years9.
Malignancy or life-threatening disease with death probable in 4 years10.
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-up11.
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], TB patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, BMI >= 45 kg/m212.
On an investigational drug in the last 3 months13.
Currently participating in a clinical trial14.
No fixed address or contact details15.
Plans to move in the next 3 years16.
A member of the participant?s household is currently in the trial17.
Inability or unwillingness of individual or legal guardian /representative to give written informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study has one primary outcome of interest, multiple CVD risk factor control targets: at least two targets including HbA1c 7.0% and at least one of: BP 130/80 mmHg or LDL-cholesterol 100 mg/dl (LDL cholesterol 70 mg/dl for those with history of CVD event).	Baseline, 3 monthly (for intervention arm only), Annually & End of Study

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (11): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
Amrita Institute of Medical Sciences
🇮🇳
,Ponekkara, India
Bangalore Endocrinology & Diabetes Research Centre
🇮🇳
Bangalore, KARNATAKA, India
CARE Hospital
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Goa Medical College
🇮🇳
Goa, GOA, India
Madras Diabetes Research Foundation
🇮🇳
Chennai, TAMIL NADU, India
MV Hospital for Diabetes & Diabetes Research Centre
🇮🇳
Chennai, TAMIL NADU, India
Osmania General Hospital
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Public Health Foundation of India
🇮🇳
Delhi, DELHI, India
St. John's Medical College & Hospital
🇮🇳
Bangalore, KARNATAKA, India
Scroll for more (1 remaining)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr. Nikhil Tandon
Principal investigator
nikhil_tandon@hotmail.com