- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01353118
The Effects of Glycemic Optimization Before Gastric Bypass Surgery (GLUCOSURG2)
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:
- whether metabolic surgery is better for diabetes control compared to medical treatment.
- whether metabolic surgery is safe for eye, nerve and kidney complications.
- whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
London, Verenigd Koninkrijk, W6 8RF
- Charing Cross Hospital
-
London, Verenigd Koninkrijk, W6 8FR
- Imperial Weight Centre, Charing Cross Hospital,
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Adult patients with T2DM and BMI above 35kg/m2
- HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.
Exclusion Criteria:
- End stage retinopathy, nephropathy or neuropathy.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Geen tussenkomst: gastric bypass
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
|
|
Actieve vergelijker: 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
|
Optimise glucose control within 3 months before operation
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
A Composite of Microvascular Complications
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Carel le Roux, MBChB, PhD, Imperial College London
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GLUCOSURG 2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Type 2 diabetes
-
University of Trás-os-Montes and Alto DouroVoltooidDiabetes mellitus type 2 | Diabetesgerelateerde complicatiesPortugal
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Nog niet aan het wervenDiabetes mellitus type 2
-
Endogenex, Inc.Nog niet aan het wervenDiabetes mellitus, type 2 | Suikerziekte | Diabetes mellitus type 2 | Type 2 diabetes | Type 2 diabetes
-
Jeil Pharmaceutical Co., Ltd.Nog niet aan het wervenDiabetes mellitus type 2Korea, republiek van
-
Nanjing First Hospital, Nanjing Medical UniversityWervingDiabetes mellitus type 2China
-
Nanjing First Hospital, Nanjing Medical UniversityWerving
-
Xiangya Hospital of Central South UniversityWerving
-
Sun Yat-sen UniversityGuangdong Provincial Hospital of Traditional Chinese Medicine; The Third Affiliated... en andere medewerkersWerving
-
BayerActief, niet wervend
-
University of Alabama at BirminghamVoltooidDiabetes mellitus type 2Verenigde Staten
Klinische onderzoeken op gastric bypass
-
Hospices Civils de LyonWerving
-
Federal State Budgetary Institution, V. A. Almazov...WervingMaagzweerRussische Federatie
-
Uppsala UniversityVoltooidObesitas | Diabetes mellitus type 2Zweden
-
Rockefeller UniversityNew York Obesity and Nutrition Research CenterBeëindigdObesitas | Gewichtsverlies | Morbide obesitasVerenigde Staten
-
University of AarhusVoltooidComplicaties na maagbypassoperatieDenemarken
-
Hospital Universitari de BellvitgeVoltooid
-
Hangzhou Tangji Medical Technology Co., Ltd.Voltooid
-
Beijing Friendship HospitalHangzhou Tangji Medical Technology Co., Ltd.Voltooid
-
Centre Hospitalier Universitaire VaudoisVoltooidObesitas | Bloeddruk | Bariatrische ChirurgieZwitserland