High intensity exercise as a possible treatment for loss of symptoms of low blood sugar in people with type 1 diabetes

High Intensity Training as a novel treatment for impaired awareness of hypoglycaemia in type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15373978

Enrollment

Registered

2019-02-08

Start date

2019-02-01

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus

Interventions

Randomisation will be carried out by an independent individual, at the University of Dundee. Randomisation will be done in a GCP-compliant manner using http://www.randomization.com/. Randomisation wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults =18 and =60 years 2. Type 1 diabetes: 2.1. >5 years disease duration 2.2. HbA1c <80 mmol/l 3. On intensive insulin therapy (continuous subcutaneous insulin infusion [CSII] or multiple daily injections [MDI]) 4. Impaired awareness of hypoglycaemia (Gold score =4 or Modified Clark score=4 or DAFNE hypoglycaemia awareness rating 2 or 3) and/or evidence of recurrent hypoglycaemia (on CGM or flash glucose monitoring)

Exclusion criteria

Exclusion criteria: 1. Competitive sportsman/woman 2. History of significant heart disease: ischaemic heart disease, congestive cardiac failure or cardiac surgery 3. Treatment with beta-blockers 4. Treatment with oral steroids within the last 6 months 5. Anaemia (Hb <120 g/L for women, Hb <130 g/L for men) 6. Renal impairment (eGFR<60) 7. History of significant lung disease – that limits exercise 8. History of significant neurological disease – those with a history of seizures second to hypoglycaemia must be seizure free for 12 months prior to consent. 9. High-risk foot disease or previous amputation of toes/foot/leg 10. Pregnant women or breastfeeding mothers 11. Participation in HIT or equivalent in pthe ast 6 months 12. Physical ability that may limit exercise 13. Inability to give consent

Design outcomes

Primary

Measure	Time frame
Adrenaline response to hypoglycaemia,measured at baseline and 30, 60 and 90 minutes into each hypoglycaemic clamp study	—

Secondary

Measure	Time frame
Measured at baseline and 30, 60 and 90 minutes into each hypoglycaemic clamp study: 1. Awareness of hypoglycaemia (Gold score, modified clark score, DAFNE awareness of hypoglycaemia score) and symptom scores (Edinburgh Hypoglycaemia Score) 2. Cognitive function (4-Choice Reaction Time test, Digit Symbol Substitution Test) 3. Well-being (The World Health Organisation- Five Well-Being Index (WHO-5)) 4. Counter regulatory hormone levels (to include glucagon, Noradrenaline (NA), lactate, Cortisol, Growth hormone (GH), insulin, cytokine panel)	—

Measure

Time frame

Measured at baseline and 30, 60 and 90 minutes into each hypoglycaemic clamp study: 1. Awareness of hypoglycaemia (Gold score, modified clark score, DAFNE awareness of hypoglycaemia score) and symptom scores (Edinburgh Hypoglycaemia Score) 2. Cognitive function (4-Choice Reaction Time test, Digit Symbol Substitution Test) 3. Well-being (The World Health Organisation- Five Well-Being Index (WHO-5)) 4. Counter regulatory hormone levels (to include glucagon, Noradrenaline (NA), lactate, Cortisol, Growth hormone (GH), insulin, cytokine panel)

—

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026