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Sponsored by: |
King's College Hospital NHS Trust |
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Information provided by: | King's College Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00472875 |
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.
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Drug: Glibenclamide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 10 |
Study Start Date: | May 2007 |
Low blood glucose (hypoglycaemia) is the most common and important side effect of insulin treatment for diabetes. Most episodes are “mild” and lead to symptoms that alert the individual to raise their blood sugar level by consuming sugar or starch (carbohydrate). The body also responds to low blood sugars by producing hormones such as adrenaline and cortisol, which help to restore blood sugar levels to normal. As the brain relies on sugar for fuel, it does not function properly if blood sugar levels drop too low, resulting in confusion and in extreme cases reduced conscious levels.
Repeated hypoglycaemia can blunt the protective symptoms and hormonal responses to hypoglycaemia limiting patients’ ability to recognise and correct hypoglycaemia, putting them at high risk of even more hypoglycaemia (Heller and Cryer, 1991).
Sulphonylureas are tablets used to treat type 2 diabetes that work by stimulating the pancreas to make more insulin. They do this by closing pores called KATP channels which are found on the surface of many cells and control the rate of firing of cells. In the pancreas, closing them causes cells to fire and release insulin. However, in other tissues such as in the brain, these channels have a protective function and they open up during times of lack of fuel, such as lack of oxygen or sugar, preventing the cells from firing and putting them into a resting mode which reduces their energy requirement(Dunn-Meynell, Rawson and Levin 1998). However, if the brain cells responsible for generating symptoms are put into this resting mode, they may not produce symptoms, which may contribute to hypoglycaemia unawareness.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pratik Choudhary, MBBS, MRCP | +44 203 299 9000 ext 2311 | pratik.choudhary@kcl.ac.uk |
Contact: Stephanie A Amiel, MD, FRCP | +44 203 299 9000 ext 4164 | stephanie.amiel@kcl.ac.uk |
United Kingdom | |
King's College Hospital NHS Foundation Trust | Recruiting |
London, United Kingdom, SE5 9RS | |
Sub-Investigator: David Hopkins, MBBS FRCP |
Principal Investigator: | Pratik Choudhary, MBBS MRCP | King's College London |
Study ID Numbers: | 07/Q0703/18, JDRF grant number 5-2007-478 |
Study First Received: | May 10, 2007 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00472875 |
Health Authority: | United Kingdom: Research Ethics Committee |
hypoglycaemia type 1 diabetes mellitus |
Glyburide Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypoglycemia |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |