NCT04284722

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 20, 2020

Last Update Submit

February 25, 2020

Conditions

HyperglycemiaMetforminType 2 DiabetesHyperlactatemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Perioperative Hyperglycemia

    blood glucose \>180mg/dl (10mmol/l) and/or necessity of additive administration of insulin s.c. during the time frame

    24 hours pre-op until 24 hours post-op

Secondary Outcomes (7)

  • Perioperative blood glucose control

    24 hours pre-op until 24 hours post-op

  • Incidence hypoglycemia

    24 hours pre-op until 24 hours post-op

  • Perioperative lactate levels

    24 hours pre-op until 24 hours post-op

  • Incidence of hyperlactatemia

    24 hours pre-op until 24 hours post-op

  • Perioperative renal function

    24 hours pre-op until 24 hours post-op

  • +2 more secondary outcomes

Study Arms (2)

Metformin +

ACTIVE COMPARATOR

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

Metformin -

NO INTERVENTION

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.

Interventions

Metformin HydrochlorideDRUG

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

Also known as: Group A
Metformin +

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Hulst AH, Polderman JAW, Ouweneel E, Pijl AJ, Hollmann MW, DeVries JH, Preckel B, Hermanides J. Peri-operative continuation of metformin does not improve glycaemic control in patients with type 2 diabetes: A randomized controlled trial. Diabetes Obes Metab. 2018 Mar;20(3):749-752. doi: 10.1111/dom.13118. Epub 2017 Oct 13.

    PMID: 28940961BACKGROUND

  • Gasanova I, Meng J, Minhajuddin A, Melikman E, Alexander JC, Joshi GP. Preoperative Continuation Versus Interruption of Oral Hypoglycemics in Type 2 Diabetic Patients Undergoing Ambulatory Surgery: A Randomized Controlled Trial. Anesth Analg. 2018 Oct;127(4):e54-e56. doi: 10.1213/ANE.0000000000003675.

    PMID: 30044293BACKGROUND

  • Kuzulugil D, Papeix G, Luu J, Kerridge RK. Recent advances in diabetes treatments and their perioperative implications. Curr Opin Anaesthesiol. 2019 Jun;32(3):398-404. doi: 10.1097/ACO.0000000000000735.

    PMID: 30958402BACKGROUND

  • Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.

    PMID: 20393934BACKGROUND

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus, Type 2Hyperlactatemia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jens Meier, MD

    Kepler University Hospital -Dpt. of Anesthesiology & Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Noitz, MD

CONTACT

+43 (0)5 7680 83 - 78171matthias.noitz@kepleruniklinikum.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Jens Meier, MD

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 26, 2020

Study Start

February 1, 2020

Primary Completion

February 1, 2021

Study Completion

April 1, 2021

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share