Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
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|ClinicalTrials.gov Identifier: NCT00472875|
Recruitment Status : Unknown
Verified May 2007 by King's College Hospital NHS Trust.
Recruitment status was: Recruiting
First Posted : May 14, 2007
Last Update Posted : May 14, 2007
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Glibenclamide||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||May 2007|
- Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia [ Time Frame: 1 year ]
- Improvement in counter regulatory hormone response to hypoglycaemia [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472875
|Contact: Pratik Choudhary, MBBS, MRCP||+44 203 299 9000 ext email@example.com|
|Contact: Stephanie A Amiel, MD, FRCP||+44 203 299 9000 ext firstname.lastname@example.org|
|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|