Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus (BY-PLUS)

Imperial College London

Status: Enrolling

Conditions: Obesity; Type 2 Diabetes

Treatments: Procedure: Bariatric surgery; Procedure: Bariatric surgery + goal directed medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04432025

20HH5928

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy. Long term diabetes care will be under the supervision of their primary care provider/general practitioner

Treatment:

Procedure: Bariatric surgery

Intervention

Experimental group

Description:

Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy and will have ongoing goal directed medical treatment for their T2DM, titrated to specific end points for BP, HbA1c and lipids.

Treatment:

Procedure: Bariatric surgery + goal directed medical therapy