Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects

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University of Aarhus

Status

Completed

Conditions

Hypoglycemia
Diabetes Mellitus, Type 1

Treatments

Other: Glucose clamp technique

Study type

Interventional

Funder types

Other

Identifiers

NCT03034226
Project 1-10-72-304-16

Details and patient eligibility

About

This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia

Full description

Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.

Enrollment

18 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Type 1 diabetics

Inclusion Criteria:

  • More than 5 years of disease duration
  • HbA1c 42-86 mmol/L
  • No known HAAF
  • BMI 22-28
  • Written consent

Exclusion Criteria:

  • Other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance
  • Medication f.x beta-blockade, steroids, psychotropics
  • Smoking
  • Drug abuse

Control subjects

Inclusion Criteria:

  • BMI 22-28
  • Written consent

Exclusion Criteria:

  • Diseases f.x diabetes, epilepsy, ischemic heart disease or heart rhythm disturbance
  • Medication f.x beta-blockade, steroids, psychotropics
  • Smoking
  • Drug abuse

Trial design

18 participants in 2 patient groups

Single episode of hypoglycemia
Active Comparator group
Description:
Day 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours
Treatment:
Other: Glucose clamp technique
Two episodes of hypoglycemia
Active Comparator group
Description:
Day 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours
Treatment:
Other: Glucose clamp technique

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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