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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-23

Study Completion Date

2019-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypoglycemia Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

9 diabetic subjects and 9 healthy control subjects will be randomized to undergo either first day 1 + day 2 (two consecutive episode of hypoglycemia) or first day 3 + day 4 (one episode of hypoglycemia).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Single episode of hypoglycemia

Day 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours

Group Type ACTIVE_COMPARATOR

Glucose clamp technique

Intervention Type OTHER

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

Two episodes of hypoglycemia

Day 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours

Group Type ACTIVE_COMPARATOR

Glucose clamp technique

Intervention Type OTHER

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

Interventions

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Glucose clamp technique

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* 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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes