Type 1 Diabetes Mellitus | Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
Type 1 Diabetes Mellitus research study
What is the primary objective of this study?
To see if using medication called sulphonylureas can help improve symptoms which patients rely on to recognise low blood glucose levels ( hypoglycaemia) and also to see if they can reduce the slowing down in brain function which occurs at hypoglycaemia.
Who is eligible to participate?
Inclusion Criteria: - Age 18-75 - Type 1 diabetes (WHO definition) of at least 5 years duration - History of impaired awareness of hypoglycaemia (capillary glucose readings < 3.5mmol/l without symptoms on > 3 occasions in the past 3 months (those with intact symptoms will be unlikely to show an improvement and would not really benefit from taking any medication intended just to increase symptoms) Exclusion Criteria: - Pregnancy - Severe systemic illness - Active malignancy - Severe complications of diabetes such as severe visual impairment, severe renal impairment, severe symptomatic autonomic neuropathy - Untreated ischemic heart disease, recent stroke - Lactose intolerance ( the placebo will contain lactose) - Very poor diabetes control (HbA1c > 10%) Liver disease ( increase in ALT / AST > 3x ULN) - Chronic Kidney Disease stage 4 or 5 ( eGFR < 30ml/min) - Severe untreated thyroid or adrenal insufficiency ( must be treated and on stable doses for at least 6 weeks)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 1 Diabetes Mellitus
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: May 2007
Phase: Phase 4
Primary Outcome: Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia
Secondary Outcome: Improvement in counter regulatory hormone response to hypoglycaemia
Study sponsors, principal investigator, and references
Principal Investigator: Pratik Choudhary, MBBS MRCP
Lead Sponsor: King's College Hospital NHS Trust