Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
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 blo
Sponsors
University of Dundee/NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 1. Competitive sportsman/woman 2. History of significant heart disease 3. Treatment with beta blockers 4. Renal impairment (eGFR<60) 5. History of significant lung disease – that limits exercise 6. History of significant neurological disease – including seizures second to hypoglycaemia 7. High risk foot disease 8. Previous amputation of toes/foot/leg 9. Pregnant women or breast feeding mothers 10. Participation in HIT or equivalent in past 6 months 11. Physical ability that may limit exercise 12. Inability to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Scotland, United Kingdom
Outcome results
None listed