Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
BY-PLUS
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2021
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
August 8, 2022
August 1, 2022
6 years
June 12, 2020
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients in each group reaching the composite end point
BP\<130/80, HbA1c\<6.5%, LDL\<2.6mmol/L
5 years
Proportion of patients reaching end point for glycemic control
HbA1c\<6.5%
1 year
Secondary Outcomes (11)
Change in body weight
5 years
Change in BMI
5 years
Change in waist circumference
5 years
Change in lipid control
5 years
Change in glycaemic control
5 years
- +6 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORPatients 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
Intervention
EXPERIMENTALPatients 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.
Interventions
Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids
Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
Eligibility Criteria
You may qualify if:
- eligible for bariatric surgery according to NICE guidelines (GC 189)
- Type 2 diabetes mellitus
- BMI \>30kg/m2
You may not qualify if:
- Recent hospitalisation in the past 30 days
- Recurrent hypoglycaemic episodes
- Recurrent hypotensive episodes
- Contraindications to bariatric surgery
- Previous bariatric surgery
- Current pregnancy
- Breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College Dublin
Dublin, Ireland
Related Publications (1)
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: 35879015DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
April 1, 2021
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 6 months
- Access Criteria
- Free access
The authors shall make data available to the scientific community with as few restrictions as feasible, ensuring anonymisation, while retaining exclusive use until the publication of major outputs.