Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

Obesity Clinical Trial

— BY-PLUS  

Official title:

Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04432025
• Other study ID #: 20HH5928
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 1, 2027

Study information

• Verified date: August 2022
• Source: Imperial College London
• Contact: Alexander Miras, MRCP
• Phone: : +44 (0)20 8383 3242
• Email: a.miras[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in each group reaching the composite end point	BP<130/80, HbA1c<6.5%, LDL<2.6mmol/L	5 years
Primary	Proportion of patients reaching end point for glycemic control	HbA1c<6.5%	1 year
Secondary	Change in body weight	Change in body weight from baseline (kg)	5 years
Secondary	Change in BMI	Change in BMI from baseline (kg/m2)	5 years
Secondary	Change in waist circumference	Change in waist circumference (cm)	5 years
Secondary	Change in lipid control	Proportion of patients achieving good lipid control (LDL<2.6mmol/L)	5 years
Secondary	Change in glycaemic control	Change in long term glycaemic control(HbA1c)	5 years
Secondary	Change in blood pressure	Proportion of patients achieving BP<130/80mmHg	5 years
Secondary	Change in liver function	Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)	5 years
Secondary	Change in renal function	Proportion of patients with normal renal function (plasma Cr, eGFR)	5 years
Secondary	Change in inflammatory markers	Reduction in CRP	5 years
Secondary	Change in urine albumin: creatinine ratio	Proportion of patients in each group with a uACR<30	5 years
Secondary	Change in quality of life	Quality of life change as determined by SF-36 and MPH-H	5 years