- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472875
Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
Study Overview
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Pratik Choudhary, MBBS, MRCP
- Phone Number: 2311 +44 203 299 9000
- Email: pratik.choudhary@kcl.ac.uk
Study Contact Backup
- Name: Stephanie A Amiel, MD, FRCP
- Phone Number: 4164 +44 203 299 9000
- Email: stephanie.amiel@kcl.ac.uk
Study Locations
-
-
-
London, United Kingdom, SE5 9RS
- Recruiting
- King's College Hospital NHS Foundation Trust
-
Sub-Investigator:
- David Hopkins, MBBS FRCP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in counter regulatory hormone response to hypoglycaemia
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pratik Choudhary, MBBS MRCP, King's College London
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/Q0703/18
- JDRF grant number 5-2007-478
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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