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Heart surgery sugar showdown: which blood sugar target saves lives?

NCT ID NCT07485101

Disease control Sponsor: Beijing Anzhen Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test two ways of controlling blood sugar during heart surgery in 3000 elderly patients with type 2 diabetes. One group will have tight control (blood sugar between 5-8 mmol/L) and the other liberal control (11-14 mmol/L). The goal is to see which approach leads to fewer major complications like death, kidney injury, heart attack, or stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insulin
What this could lead to
If it works, this could point toward a safer way to manage blood sugar during heart surgery for elderly diabetics, reducing the risk of major complications like kidney injury or stroke.
What could go wrong
This trial hasn't started yet, and it's comparing two existing strategies rather than testing a new drug. The results may not apply to younger patients or those without diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: age ≥ 60 years old. 2. Diagnosis: Preoperative diagnosis of Type 2 Diabetes Mellitus (T2DM), with a history of regular glucose-lowering therapy for at least 3 months prior to surgery. 3. Procedure: Undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB). 4. Complexity: Undergoing combined cardiac procedures (e.g., any combination of two or more of the following: CABG, valvular surgery, congenital heart repair, cardiomyopathy correction, or great vessel surgery). 5. Informed Consent: Willing and able to provide written informed consent. Exclusion Criteria: 1. Surgical Factors: Emergency surgery, redo sternotomy, heart transplantation, or left ventricular assist device (LVAD) implantation. 2. Organ Dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or pre-existing dependence on renal replacement therapy (RRT). 3. Neurological Status: History of severe disabling stroke (mRS \> 3) or dementia that prevents meaningful neurological assessment. 4. Acute Metabolic Complications: Occurrence of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within 1 month prior to surgery, or a history of recurrent severe hypoglycemia within the past year. 5. Glycemic Baseline: Preoperative HbA1c \> 10%. 6. Pregnancy/Lactation: Women who are currently pregnant or breastfeeding. 7. Life Expectancy: Terminal illness with an expected survival of less than 3 months. 8. Communication Barriers: Inability to effectively communicate or provide informed consent due to mental, legal, or other disabilities. 9. Co-enrollment: Concurrent participation in another perioperative interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glycemic management during CPB in elderly diabetic cardiac surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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