A Phase 4 interventional study of Metformin Hydrochloride in Hyperglycemia, Metformin and Type 2 Diabetes, sponsored by Kepler University Hospital. Status unknown. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Kepler University Hospital · Phase 4, Interventional, and Prevention
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.
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.
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 400 is above the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Kepler University Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Metformin Hydrochloride
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.
Perioperative continuation of oral metformin therapy according to the patient's normal dosage and dosage intervals
Also known as: Group A
Incidence of Perioperative Hyperglycemia
blood glucose \>180mg/dl (10mmol/l) and/or necessity of additive administration of insulin s.c. during the time frame
Time frame: 24 hours pre-op until 24 hours post-op
Perioperative blood glucose control
mean plasma glucose at 4 defined dates: 24h pre-op, intra-op, 2hours post-op and 24h post-op
Time frame: 24 hours pre-op until 24 hours post-op
Incidence hypoglycemia
blood sugar levels \< 70mg/dl (3.9mmol/l)
Time frame: 24 hours pre-op until 24 hours post-op
Perioperative lactate levels
mediane lactate levels at 4 defined dates: 24h pre-op, intra-op, 2 hours post-op and 24h post-op
Time frame: 24 hours pre-op until 24 hours post-op
Incidence of hyperlactatemia
blood lactate values \>4mmol/L at least at one of 4 measurement dates: 24h pre-op, intra-op, 2 hours post-op, 24 hours post-op
Time frame: 24 hours pre-op until 24 hours post-op
Perioperative renal function
median serum-creatinine value at 24h pre-op and 24h post-op
Time frame: 24 hours pre-op until 24 hours post-op
Hospitalization Duration
median time period from day of surgery until discharge from hospital
Time frame: up to 4 weeks
Mortality
In-Hospital mortality
Time frame: up to 4 weeks
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Kepler University Hospital