Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT01501201 En recrutement IDF

Titre

Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study

Type

Interventional

Pathologie

Obésité

Phase

Phase 4

Promoteur

University Hospital, Lille (Voir sur ClinicalTrials)

Date de début

août 2011

Date de fin

septembre 2029

Dernière mise à jour

14 septembre 2025

Résumé

The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

Détail

Voir le détail Optimizing the management of type 2 diabetes (T2D) will remain a major public health concern for decades to come. T2DM has already affected 4% of the French population and generates each year over 12 billion euros of expenditure. By combining therapies, oral and/or injectable (insulin or analogues of GLP-1), the current management of T2DM provides two thirds of patients with a satisfactory metabolic control (HbA1c < 7%) and reduced incidence of cardiovascular complications. Its effect on mortality, however, remains more limited, presumably because of the persistence of other cardiovascular risk factors. A recent study has confirmed that French patients with T2DM present an overall mortality risk significantly higher than the general population. In France, this group registered a mortality of 32 deaths per 1000 persons. Bariatric surgery is now a recognized method for the treatment of severe obesity. It allows for the permanent loss of at least 50% of initial excess weight. In obese patients, this surgery is also associated with a significant reduction in cardiovascular risk factors and particularly T2D. A recent meta-analysis of retrospective studies available suggests that surgery results in remission of T2DM in over 75% of cases. The only prospective randomized study showed that gastric restriction by placing a gastric band, provides better glycemic control than just medical treatment in obese patients with recently discovered T2DM. The gastric by-pass (GBP) which also includes an intestinal by-pass, seems to have an even higher metabolic efficiency than gastric bypass alone. In patients with T2DM, the GBP restores postprandial insulin secretion independently of weight loss. Despite the significant morbidity of the intervention, long-term results seem broadly supportive of the GBP. In a large case-control study, GBP was associated with a decrease of 90% of deaths related to diabetes. In a controlled study conducted in surgical candidates obese diabetics, the GBP decreased the overall world mortality by 75% after 6 years. Despite these very encouraging data, the GBP is now proposed to only a small proportion (< 1%) of patients likely to benefit from the procedure. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Ambroise Paré		En recrutement IDF	Contact (sur clinicalTrials)
AP-HP - Hôpital La Pitié-Salpêtrière		En recrutement IDF	Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Ch Valenciennes - Valenciennes - France		En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Regional D' Angers - Angers - France		En recrutement	Contact (sur clinicalTrials)
Hopital de Bois-Guillaume Chu Rouen - Bois-Guillaume - France		En recrutement	Contact (sur clinicalTrials)
Hopital Jeanne D'Arc Chu Nancy - Dommartin Les Toul - France		En recrutement	Contact (sur clinicalTrials)
Hopital Lapeyronie Chu Montpellier - Montpellier - France		En recrutement	Contact (sur clinicalTrials)
Hopital Larrey Chu Toulouse - Toulouse - France		En recrutement	Contact (sur clinicalTrials)
Hopital Lyon Sud - Hcl - Pierre Benite - 69008 - Lyon - France		En recrutement	Contact (sur clinicalTrials)
University Hospital of Lille - 59000 - Lille - Nord - France	Violeta Raverdy, MD	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Type 2 diabetes mellitus with HbA1c > 7.5 %

- Body mass index > 35 and < 50 kg/m2

- Candidate for Gastric By-Pass

- Treatment with GLP1 (glucagon-like peptide) analogue or insulin

Critère de non inclusion

- Contraindication to bariatric surgery

- Pregnancy

- Affiliation of health care assurance

- Psychiatric disorders

NCT01501201 - Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study

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