Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric surgery + goal directed medical therapy, Bariatric surgery.
- Who it may be relevant to
- Registry conditions: Obesity, Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Bariatric 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 - Procedure Bariatric surgery
Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
Primary outcome measures
- Proportion of patients in each group reaching the composite end point [Time frame: 5 years]
- Proportion of patients reaching end point for glycemic control [Time frame: 1 year]
Secondary outcome measures (11)
- Change in body weight [Time frame: 5 years]
- Change in BMI [Time frame: 5 years]
- Change in waist circumference [Time frame: 5 years]
- Change in lipid control [Time frame: 5 years]
- Change in glycaemic control [Time frame: 5 years]
- Change in blood pressure [Time frame: 5 years]
- Change in liver function [Time frame: 5 years]
- Change in renal function [Time frame: 5 years]
- Change in inflammatory markers [Time frame: 5 years]
- Change in urine albumin: creatinine ratio [Time frame: 5 years]
- Change in quality of life [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ireland · 1 center
- University College Dublin — Dublin
Publications
- Sudlow A, Miras AD, Cohen RV, Kahal H, Townley J, Heneghan H, Le Roux C, Pournaras DJ. Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study. BMJ Open. 2022 Jul 25;12(7):e054313. doi: 10.1136/bmjopen-2021-054313. PMID 35879015
Identifiers
NCT: NCT04432025 · 20HH5928