Dishabituation as a treatment for impaired awareness of hypoglycaemia in type 1 diabetes

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participants will be randomised to start with a period of rest or a high intensity exercise program on an exercise bike. The following day they will undergo a hypoglycaemic clamp study where their blood glucose level will be reduced in a controlled manner and their response monitored in the form of blood tests and questionnaires. Participants will cross over two weeks later to undergo the opposite intervention and again undergo a hypoglycaemic clamp study. There will be 5‐7 visits to the Clinical Research Centre, the study will last approximately 6 weeks in total. CONDITION: Type 1 diabetes ; Nutritional, Metabolic, Endocrine ; Type 1 diabetes mellitus PRIMARY OUTCOME: The difference in the adrenaline response to hypoglycaemia following the HIT and no exercise protocols, measured at baseline, immediately post HIT intervention and ‐30, 0, 30, 60 and 90 minutes into hypoglycaemic clamp SECONDARY OUTCOME: 1. Changes in awareness of hypoglycaemia and symptom scores (Edinburgh Hypoglycaemia Score), measured at baseline, immediately post intervention and ‐30, 0, 30, 60 and 90 minutes ± 10 minutes into hypoglycaemic clamp; 2. Changes in cognitive function (Digital Symbol Substitution Test, 4‐Choice Reaction Time), measured at baseline, immediately post intervention and ‐30, 0, 30, 60 and 90 minutes ± 10 minutes into hypoglycaemic clamp; 3. Changes in mood (standard validated psychometric measures of mood state), measured at baseline, immediately post intervention and ‐30, 0, 30, 60 and 90 minutes ± 10 minutes into hypoglycaemic clamp; 4. Changes in other counter regulatory hormones (glucagon, noradrenaline, lactate, cortisol, growth hormone, insulin, cytokine panel and brain derived neurotrophic factor), measured at baseline both interventions, immediately post HIT intervention and ‐30, 0, 30, 60 and 90 minutes ± 10 minutes into hypoglycaemic clamp (insulin will only be measured during hypoglycaemic clamp study) INCLUSION CRITERIA: 1. Adults =18 and = 55 years 2. Type 1 diabetes 3. > 5 years disease duration 4. HbA1c < 75 mmol/l 5. On intensive insulin therapy (CSII or MDI) 6. Impaired awareness of hypoglycaemia (Gold score =4 or Modified Clark score=4 or DAFNE hypoglycaemia awareness rating 2 or 3)
Epistemonikos ID: 54eeb2dc66135c3e931d5528796c50e5addc262d
First added on: Aug 23, 2024