Perioperative Continuation of Metformin Therapy in Patients With Typ 2 Diabetes Mellitus Undergoing Non-cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of the effect of peri-operative continuation of oral metformin therapy on the incidence of perioperative hyperglycemia compared to standard preoperative cessation of oral metformin therapy 24h before surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Type 2 Diabetes and Ambulatory Surgery Patients

NCT03179254

Diabetes Type 2

COMPLETED PHASE4

The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

NCT00487162

Hyperglycemia

TERMINATED NA

Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?

NCT00468494

General Anesthesia Hyperglycemia

COMPLETED

SHOrt-term Glycemic Control for Reducing Post-SURGical Complications

NCT06334068

Diabetes Uncontrolled Diabtetes

COMPLETED NA

Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial

NCT05314725

Postoperative Hyperglycemia Stress Hyperglycemia

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Surgical procedures cause metabolic stress and can impair glucose control especially in patients with diabetes mellitus, which often results in peri-operative hyperglycemia. Peri-operative hyperglycemia is associated with impaired wound healing, secondary wound infections, endothelial dysfunction, sepsis, prolonged hospital stay and higher mortality.

Metformin is still the first line treatment in patients with type 2 diabetes mellitus.

Historically it has been stopped before surgery due to fear of hypoglycemia and metformin induced lactic acidosis. However recent studies have suggested that perioperative continuation of metformin might be safe and patients could benefit from more stable preoperative blood sugar levels.

Prospective studies evaluating the benefit of continuing oral metformin therapy in the perioperative period are rare.

The investigators plan to conduct a prospective, randomized-controlled, unblinded clinical trial where patients with type II diabetes mellitus and oral metformin therapy undergoing non-cardiac surgery will be randomized in either an interventional group or a control group. In the interventional group patients will be instructed to continue their regular metformin dose even on the day of surgery, in contrast to the control group, where the patients will be instructed to stop taking metformin 24h prior to surgery.

All other oral anti-diabetic drugs will be paused according to the local anesthesia guidelines.

The investigators plan to evaluate whether or not continuation of metformin can reduce the incidence of perioperative hyperglycemia and whether or not it is associated with elevation of blood lactate levels.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia Metformin Type 2 Diabetes Hyperlactatemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metformin +

The study intervention involves the self-administration of metformin in the same dosage as the patient's regular dosage according to regular dosing schedule and randomization.

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type DRUG

Perioperative continuation of oral metformin therapy according to the patient's normal dosage and dosage intervals

Metformin -

The control group involves no intervention, which means cessation of oral metformin therapy 24 hours prior to surgery according to the local guidelines of the anesthesia department and the national anesthesiology guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin Hydrochloride

Perioperative continuation of oral metformin therapy according to the patient's normal dosage and dosage intervals

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Group A

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-99 years
* Diabetes Mellitus Typ 2
* Oral metformin therapy
* Non cardiac-surgery
* Informed consent

Exclusion Criteria

* Insulin therapy
* Ambulatory surgery
* Preoperative therapy with glucocorticoids (prednisolon or equivalent ≥ 5mg/day for more than 7 days)
* Planned postoperative ICU-stay
* Advanced renal insufficiency (eGFR \< 45ml/kg/min)
* Advanced liver cirrhosis or failure (Child-Pugh B or C)
* Alcohol abuse
* Pregnancy,
* Perioperative administration of contrast dye

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No