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Blood sugar control after bypass operation - insulin vs oral medication

A randomized controlled trial to compare insulin and metformin versus metformin and sulphonyluria on the short term outcomes after Coronary Artery bypass graft (CABG) in patients with type 2 diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2014/024
Enrollment
330
Registered
2014-10-07
Start date
2014-10-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart disease, diabetes

Interventions

Consenting patients will be randomized into two arms using a random number table. Randomization will be done around post operative day three when the patient has achieved satisfactory glycaemic contro

Sponsors

National Hospital of Sri Lanka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes admitted to Cardio-thoracic units of the National Hospital of Sri Lanka for coronary artery bypass grafting (CABG) 2. Daily insulin requirement of <1IU/kg/day to achieve satisfactory glycaemic control

Exclusion criteria

Exclusion criteria: 1. Patients on insulin prior to admission due to oral hypoglycaemic (OHG) failure 2. Daily insulin requirement following CABG >1IU/kg/day. 3. Serum creatinine > 1.5 mg/dl 4. Unstable cardiac failure 5. Chronic liver disease 6. Patients taking drugs affecting glycaemic control (eg. Steroids) 7. Patients unable to return for follow-up 8. Patients who are unable to understand or cooperate with protocol requirements

Design outcomes

Primary

MeasureTime frame
1. HbA1c 2. FBG 3. PPBG [1. HbA1c will be done at 3 months after discharge 2. FBG and PPBG will be done at one week, one month, two months and three months after discharge ]

Secondary

MeasureTime frame
1. Surgical wound infection occurring within 30 days of surgery (at least one of the following: purulent discharge from surgical site or drain, organisms isolated from aseptically obtained wound culture, signs and symptoms of infection such as pain or tenderness, localized swelling, or redness/heat). 2. Acute coronary syndrome: Angina associated with dynamic ECG changes and or raised troponin levels 3. Heart failure 4. Stroke 5. Hypoglycaemia (RBG < 70 mg/dL or 3.9 mmol/L) 6. Weight change (5% weight loss or gain over three months) [Monthly after discharge for 3 months]

Countries

Sri Lanka

Contacts

Public ContactLalana Devi Ranasinghe

Senior Registrar in Endocrinology

lalana.devi@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026