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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1; Hypoglycemia
• Interventions: Other: Glucose clamp technique

• Registration Number: NCT03034226
• Lead Sponsor: University of Aarhus

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-02-23
• Primary Completion: 2018-02-01
• Status Verified: 2018-03
• Study Completion: 2019-01-01
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	Day 2 and day 4 (T=60 minutes - T=240 minutes)	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

Secondary Outcome Measures

Name	Time	Method
Symptoms during hypoglycemia	Day 2 and day 4 (T=0 minutes - T=420 minutes)	Using the Edinburgh Hypoglycemia Scale (symptom scale) we will interview the subjects regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp
Hormonal counter regulatory response to hypoglycemia	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	Hormonal counter regulatory response (epinephrine, norepinephrine, glucagon, cortisol, ghrelin etc.) measured regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp

Trial Locations

Locations (1)

Department of Clinical Medicine; 🇩🇰 Aarhus, Denmark