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Clinical Trial Details

Trial ID: L4516
Source ID: NCT01488136
Associated Drug: Diazoxide
Title: Use of Diazoxide in Acute Hypoglycaemia
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Diazoxide|DRUG: Placebo
Outcome Measures: Primary: Adrenaline response(pmol/L) at 2.5mmol/L of glucose, The body secretes hormones such as adrenaline as a response to low blood sugars. Patients who have had insulin-dependant diabetes for over 5 years rely heavily on adrenaline release, to produce symptoms, so that they can respond appropriately to low blood sugars. However, this response is blunted in those with type 1 diabetes. Our question is whether the magnitude of this response can be increased by use of diazoxide in the context of hypoglycaemia, so that patients with insulin-dependant diabetes become better aware of hypoglycaemia., 1 year | Secondary: Glucose Thresholds (calculated when counter-regulatory hormone release is greater than 2SD of hormone level at euglycaemia 4.0mmol/L blood sugar) of each of the counter-regulatory hormones (adrenaline, noradrenalin, glucagon), Our study design enables us to bring down the blood sugar in a controlled fashion and maintain it at certain levels. We will be measuring hormones including adrenaline and testing cognitive function as well as assessing symptoms at each of these blood sugar levels. We want to see if diazoxide affects the threshold at which patients are able to mount a clinically relevant rise in counter-regulatory hormones and symptoms of hypoglycaemia., 1 year | Other: Symptom scores and Cognitive function scores at 2.5mmol/L, Symptom scores will be assessed using the Edinburgh Hypoglycaemia Symptom score assesment, and Cognition will be assessed using Trail Making B, Digit substituition, Digit forward and backward and 4 choice reaction tests., Done during the hyperinsulinaemic hypoglycaemic clamp
Sponsor/Collaborators: Sponsor: University of Dundee | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT
Phases: PHASE4
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2012-01
Completion Date: 2013-03
Results First Posted:
Last Update Posted: 2019-10-14
Locations: NHS Tayside, Dundee, DD1 9SY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01488136