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.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Cardiometabolic diseases - Type 2 diabetes mellitusHealth Condition 2: E115- Type 2 diabetes mellitus with circulatory complications

• Registration Number: CTRI/2010/091/001185
• Lead Sponsor: ational Heart Lung and Blood Institute National Institutes for Heath USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-10-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1146

Inclusion Criteria

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

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. Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigators assessment the patient is likely to follow-up regularly as required by the protocol.

5. 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 mellitus
2. Diabetes secondary to chronic pancreatitis
3. Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth
control (including natural methods)
4. 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
5. Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12
months
6. Current symptomatic CHF or NYHA Class 3 or 4 effort intolerance
7. 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 years
9. Malignancy or life-threatening disease with death probable in 4 years
10. 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
11. 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/m2
12. On an investigational drug in the last 3 months
13. Currently participating in a clinical trial
14. No fixed address or contact details
15. Plans to move in the next 3 years
16. A member of the participant?s household is currently in the trial
17. Inability or unwillingness of individual or legal guardian /representative to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified