RecruitingNot ApplicableNCT04432025

Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus


Sponsor

Imperial College London

Enrollment

150 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • eligible for bariatric surgery according to NICE guidelines (GC 189)
  • Type 2 diabetes mellitus
  • BMI \>30kg/m2

Exclusion Criteria7

  • Recent hospitalisation in the past 30 days
  • Recurrent hypoglycaemic episodes
  • Recurrent hypotensive episodes
  • Contraindications to bariatric surgery
  • Previous bariatric surgery
  • Current pregnancy
  • Breastfeeding

Interventions

PROCEDUREBariatric surgery + goal directed medical therapy

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

PROCEDUREBariatric surgery

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


Locations(1)

University College Dublin

Dublin, Ireland

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NCT04432025


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