- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02571608
Continuation of Metformin to Improve And Keep Peri-operative Glycemic Control (CANTAKE)
8. juli 2026 opdateret af: McMaster University
ContinuAtioN of meTformin to Improve And KEep Peri-operative Glycemic Control: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.
Type II Diabetes Mellitus patients having surgery who adhere to their regular scheduled metformin dosing and take this medication on the morning of surgery will have better glycemic control peri-operatively and potentially suffer less morbidity compared to individuals taking a placebo.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Peri-operative hyperglycemia has been linked to numerous negative adverse consequences, including wound infection, impaired wound healing, endothelial dysfunction, neurocognitive dysfunction, sepsis, prolonged hospital stay and increased mortality.
This has been shown in numerous studies as outlined in our detailed research proposal.
The peri-operative period includes a timeframe ranging from 12 to 72 hours around the time of surgery according to definition.
Our study is examining glycemic control in the peri-operative period which we are defining as approximately 48 hours around the time of surgery.
The majority of the patients with type II diabetes take oral medications, such as metformin, to control their blood sugar.
These patients have historically held their doses on the day of the surgery to avoid possible low blood sugar and lactic acidosis while fasting.
However, numerous recent studies have shown that individuals who are fasting without renal, heart and liver failure are safe to take metformin.
The most recent guidelines from the American diabetes association suggest that patients should take their dose of metformin on the day of surgery.
Despite these recommendations most anesthesiologists continue to withhold metformin on the day of surgery, as no studies exist to show the benefit of continuing metformin.
If we are able to show that patients taken metformin have better glycemic control during this time we can extrapolate that result mean they may have a lower incidence of the consequences linked to poor glycemic control.
Undersøgelsestype
Interventionel
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- ages 18 - 75, using metformin for control of Type II Diabetes mellitus, American Society of Anesthesiologists(ASA) I, II and III, informed consent, surgery in which less than 1000 mL of blood loss is expected.
Exclusion Criteria:
- renal failure, liver failure, Congestive heart failure (CHF), previous episodes of hypoglycemia, conditions which mask symptoms of hypoglycemia (autonomic neuropathy or chronic high dose beta-blocker usage), low capillary blood sugar (CBG) (≤4.0 mmol/L) at pre-operative appointment date, same day surgery, any patient who received contrast dye within 2 days of the planned surgery or requires intra-operative contrast dye and same day surgery.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
The study intervention involves Type II Diabetes Mellitus patient self-administered metformin vs. placebo according to regular dosing schedule and randomization.
Both placebo and active drug will be over-encapsulated by pharmacy so that they will be indistinguishable to the personnel involved in the study.
Andre navne:
|
|
Aktiv komparator: Metformin
Metformin, dosage same as the patient's regular dosage
|
The study intervention involves Type II Diabetes Mellitus patient self-administered metformin vs. placebo according to regular dosing schedule and randomization.
Both placebo and active drug will be over-encapsulated by pharmacy so that they will be indistinguishable to the personnel involved in the study.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: One year
|
This will be documented as total number of individuals recruited and randomized in the study.
|
One year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Glycemic control
Tidsramme: Baseline, Intra-op, 1, 6, 12, 24 and 48 hours post-op
|
Mean CBG score difference between 2 groups
|
Baseline, Intra-op, 1, 6, 12, 24 and 48 hours post-op
|
|
Wound infection
Tidsramme: At follow up visit with surgeon at approx. 6 weeks post-surgery
|
Wound infection present at follow-up visit
|
At follow up visit with surgeon at approx. 6 weeks post-surgery
|
|
Length of Hospital Stay
Tidsramme: One year
|
Mean length of stay for all patients
|
One year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: James Paul, MD, FRCPC, McMaster University
- Ledende efterforsker: Russell Brown, MDMC, PhD, FRCPC, McMaster University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. januar 2022
Primær færdiggørelse (Anslået)
31. december 2022
Studieafslutning (Anslået)
31. december 2022
Datoer for studieregistrering
Først indsendt
29. september 2015
Først indsendt, der opfyldte QC-kriterier
6. oktober 2015
Først opslået (Anslået)
8. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-152
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