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

Not Applicable

Completed

• Conditions: Type 1 diabetes mellitus; Type 1 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN15373978
• Lead Sponsor: niversity of Dundee/NHS Tayside

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33532608/ protocol (added 08/02/2021) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32820010/ (added 28/10/2022) 2023 Results article in https://doi.org/10.1007/s00125-023-06051-x (added 28/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Study Completion: 2021-04-26
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

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

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 breast feeding mothers
11. Participation in HIT or equivalent in past 6 months
12. Physical ability that may limit exercise
13. Inability to give consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adrenaline response to hypoglycaemia,measured at baseline and 30, 60 and 90 minutes into each hypoglycaemic clamp study

Secondary Outcome Measures

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