Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by King's College Hospital NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00472875
First received: May 10, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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
Type 1 Diabetes Mellitus
Drug: Glibenclamide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Improvement in counter regulatory hormone response to hypoglycaemia [ Time Frame: 1 year ]

Estimated Enrollment: 10
Study Start Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472875

Contacts
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

Locations
United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Sub-Investigator: David Hopkins, MBBS FRCP         
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Pratik Choudhary, MBBS MRCP King's College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00472875     History of Changes
Other Study ID Numbers: 07/Q0703/18, JDRF grant number 5-2007-478
Study First Received: May 10, 2007
Last Updated: May 10, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by King's College Hospital NHS Trust:
hypoglycaemia
type 1 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014