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

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

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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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