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

University of Aarhus18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypoglycemia Diabetes Mellitus, Type 1

Interventions

Glucose clamp techniqueOTHER

Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Clinical Medicine

Aarhus, Denmark

Outcomes

Primary Outcomes

Insulin sensitivity

Insulin sensitivity before, during hypoglycemia and after recovery from hypoglycemia on day 2 (one episode of hypoglycemia) compared with day 4 (two consecutive episodes of hypoglycemia). Insulin sensitivity is measured as M-value derived from the Glucose Infusion Rate (GIR) during a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp

Time frame: Day 2 and day 4 (T=60 minutes - T=240 minutes)

Secondary Outcomes

Hormonal counter regulatory response to hypoglycemia

Hormonal counter regulatory response (epinephrine, norepinephrine, glucagon, cortisol, ghrelin etc.) measured regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp

Time frame: Day 2 and day 4 (T=0 minutes, T=30, T=40, T=50, T=120, T=130, T=140, T160, T=170, T=180, T=210, T=220, T=230, T=390, T=400 and T=410

Symptoms during hypoglycemia

Using the Edinburgh Hypoglycemia Scale (symptom scale) we will interview the subjects regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp

Time frame: Day 2 and day 4 (T=0 minutes - T=420 minutes)

Data from ClinicalTrials.gov

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