Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
Primary Purpose
Type 1 Diabetes Mellitus
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Glibenclamide
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring hypoglycaemia, type 1 diabetes mellitus
Eligibility Criteria
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)
Sites / Locations
- King's College Hospital NHS Foundation TrustRecruiting
Outcomes
Primary Outcome Measures
Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia
Secondary Outcome Measures
Improvement in counter regulatory hormone response to hypoglycaemia
Full Information
NCT ID
NCT00472875
First Posted
May 10, 2007
Last Updated
May 10, 2007
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00472875
Brief Title
Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
hypoglycaemia, type 1 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glibenclamide
Primary Outcome Measure Information:
Title
Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Improvement in counter regulatory hormone response to hypoglycaemia
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pratik Choudhary, MBBS, MRCP
Phone
+44 203 299 9000
Ext
2311
Email
pratik.choudhary@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie A Amiel, MD, FRCP
Phone
+44 203 299 9000
Ext
4164
Email
stephanie.amiel@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratik Choudhary, MBBS MRCP
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hopkins, MBBS FRCP
12. IPD Sharing Statement
Learn more about this trial
Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
We'll reach out to this number within 24 hrs