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The Effects of Glycemic Optimization Before Gastric Bypass Surgery (GLUCOSURG2)

11. januar 2022 opdateret af: Carel Le Roux, Imperial College London

Investigation of the Effects of Glycaemic Optimisation Before Gastric Bypass Surgery on the Glycaemic Remission and Microvascular Complication Rates of Type 2 Diabetes Mellitus

Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether:

  • metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission.
  • metabolic surgery is safe for microvascular complications of Type 2 diabetes
  • good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes.

This study aims to assess:

  1. whether metabolic surgery is better for diabetes control compared to medical treatment.
  2. whether metabolic surgery is safe for eye, nerve and kidney complications.
  3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. The surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group).

Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.

Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia.

Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, W6 8RF
        • Charing Cross Hospital
      • London, Det Forenede Kongerige, W6 8FR
        • Imperial Weight Centre, Charing Cross Hospital,

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult patients with T2DM and BMI above 35kg/m2
  2. HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.

Exclusion Criteria:

  • End stage retinopathy, nephropathy or neuropathy.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: gastric bypass
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Aktiv komparator: Gastric bypass 2
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia
Biologisk: gastric bypass
Optimise glucose control within 3 months before operation
Andre navne:
  • Type 2 diabetes
  • glucose optimisation
  • microvascular complications
  • retinopathy
  • neuropathy
  • nephropathy
  • Gastric bypass with

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.
Tidsramme: 1 year

A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission.

The outcome measure is calculated as the count of participants achiving the above criteria
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
A Composite of Microvascular Complications
Tidsramme: 1 year

A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.

The outcome measure is calculated as the count of participants developing any of the microvascular events.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Imperial College London

Efterforskere

  • Ledende efterforsker: Carel le Roux, MBChB, PhD, Imperial College London

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

1. maj 2011

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

11. maj 2011

Først indsendt, der opfyldte QC-kriterier

11. maj 2011

Først opslået (Skøn)

12. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GLUCOSURG 2

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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