Clinical trial

Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

Recruiting now · Not applicable · 1 countries · Registry ID NCT04432025

Recruiting nowNot applicableInterventional

What this study is about

The aim of this study is to investigate the continued usage of standard diabetes medications in the post operative period following bariatric surgery to determine whether this approach may improve long term diabetes control. At present, the standard of treatment in patients with type 2 diabetes is that all medication is stopped in the immediate postoperative period and only re-started if symptoms of diabetes re-emerge. Although a large proportion of patients with diabetes will initially go in to remission, 80% experience relapse within five years. This study is needed to determine whether continuing medications is not only safe but will improve long term outcomes for patients with diabetes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Type 2 Diabetes

Full registry criteria

Inclusion Criteria: * eligible for bariatric surgery according to NICE guidelines (GC 189) * Type 2 diabetes mellitus * BMI \>30kg/m2 Exclusion Criteria: * Recent hospitalisation in the past 30 days * Recurrent hypoglycaemic episodes * Recurrent hypotensive episodes * Contraindications to bariatric surgery * Previous bariatric surgery * Current pregnancy * Breastfeeding

Treatments and study arms

Bariatric surgery + goal directed medical therapy

Procedure

Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids

Bariatric surgery

Procedure

Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner

Primary outcomes

Proportion of patients in each group reaching the composite end point5 years

BP\<130/80, HbA1c\<6.5%, LDL\<2.6mmol/L

Proportion of patients reaching end point for glycemic control1 year

HbA1c\<6.5%

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University College Dublin🇮🇪 Dublin, Ireland

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Carel le Roux, PhDContact