Obesity, Type 2 Diabetes
Conditions
Keywords
obesity, type 2 diabetes
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.
Interventions
PROCEDUREBariatric 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
PROCEDUREBariatric surgery
Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomly allocated to the control arm (bariatric surgery- either RYGB or SG) or intervention (bariatric surgery- either RYGB or SG + goal directed medical therapy for t2DM)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in each group reaching the composite end point | 5 years | BP\<130/80, HbA1c\<6.5%, LDL\<2.6mmol/L |
| Proportion of patients reaching end point for glycemic control | 1 year | HbA1c\<6.5% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | 5 years | Change in waist circumference (cm) |
| Change in lipid control | 5 years | Proportion of patients achieving good lipid control (LDL\<2.6mmol/L) |
| Change in glycaemic control | 5 years | Change in long term glycaemic control(HbA1c) |
| Change in blood pressure | 5 years | Proportion of patients achieving BP\<130/80mmHg |
| Change in body weight | 5 years | Change in body weight from baseline (kg) |
| Change in renal function | 5 years | Proportion of patients with normal renal function (plasma Cr, eGFR) |
| Change in inflammatory markers | 5 years | Reduction in CRP |
| Change in urine albumin: creatinine ratio | 5 years | Proportion of patients in each group with a uACR\<30 |
| Change in quality of life | 5 years | Quality of life change as determined by SF-36 and MPH-H |
| Change in liver function | 5 years | Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST) |
| Change in BMI | 5 years | Change in BMI from baseline (kg/m2) |
Countries
Ireland
Contacts
Primary ContactAlexander Miras, MRCP
Outcome results
None listed