Obesity Clinical Trial
— BY-PLUSOfficial title:
Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
NCT number | NCT04432025 |
Other study ID # | 20HH5928 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | August 1, 2027 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Ireland | University College Dublin | Dublin |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
Ireland,
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 |
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