Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

An experimental observational case-control study. The overall objective is to gain new knowledge about mechanisms involved in adaptation to recurrent hypoglycaemia in diabetes by investigating patients with type 1 diabetes and healthy controls. The knowledge to be obtained may feed into experimental hypoglycaemic clamp studies to further elucidate the effect of the adaptations during acute hypoglycaemia. Ultimately, it may lead to intervention studies aiming at the maintenance of functional capability during hypoglycaemia in patients with type 1 diabetes to reduce their risk of severe hypoglycaemia.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nordsjaellands Hospital
• Collaborators: Danish Research Centre for Magnetic Resonance; Steno Diabetes Center Copenhagen; University of Copenhagen
• Treatments: Epinephrine; Glucagon; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Ability to provide written informed consent

2. Male or female aged 18-70 years

3. Must be able to speak and read Danish

4. Type 1 diabetes patients with HbA1c <48 mmol/mol (Case A) or >70 mmol/mol (Case B)

5. CGM-documented frequent exposure to hypoglycaemia (Case A) or CGM without hypoglycaemia (Case B) for 6 days.

6. A documented clinically relevant history of type 1 diabetes

7. In insulin treatment regimen

8. The subject must be willing and able to comply with trial protocol

Exclusion Criteria:

1. History of severe psychological condition

2. History of severe heart disease

3. History of epilepsy, former apoplexies and dementia

4. History of muscle diseases

5. History of liver disease

6. History of malignancy unless a disease-free period exceeding 5 years

7. Implants not compatible for MRI scans

8. History of alcohol or drug abuse

9. Pregnant or lactating woman