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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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
University College Dublin
Dublin, Ireland
RECRUITINGProportion of patients in each group reaching the composite end point
BP\<130/80, HbA1c\<6.5%, LDL\<2.6mmol/L
Time frame: 5 years
Proportion of patients reaching end point for glycemic control
HbA1c\<6.5%
Time frame: 1 year
Change in body weight
Change in body weight from baseline (kg)
Time frame: 5 years
Change in BMI
Change in BMI from baseline (kg/m2)
Time frame: 5 years
Change in waist circumference
Change in waist circumference (cm)
Time frame: 5 years
Change in lipid control
Proportion of patients achieving good lipid control (LDL\<2.6mmol/L)
Time frame: 5 years
Change in glycaemic control
Change in long term glycaemic control(HbA1c)
Time frame: 5 years
Change in blood pressure
Proportion of patients achieving BP\<130/80mmHg
Time frame: 5 years
Change in liver function
Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)
Time frame: 5 years
Change in renal function
Proportion of patients with normal renal function (plasma Cr, eGFR)
Time frame: 5 years
Change in inflammatory markers
Reduction in CRP
Time frame: 5 years
Change in urine albumin: creatinine ratio
Proportion of patients in each group with a uACR\<30
Time frame: 5 years
Change in quality of life
Quality of life change as determined by SF-36 and MPH-H
Time frame: 5 years
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