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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034226
• Other study ID #: Project 1-10-72-304-16
• Status: Completed
• Phase: N/A
• Start date: February 23, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 1, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Other:
• Glucose clamp technique
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose

Locations

Country	Name	City	State
Denmark	Department of Clinical Medicine	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 2 and day 4 (T=60 minutes - T=240 minutes)
Secondary	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	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
Secondary	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	Day 2 and day 4 (T=0 minutes - T=420 minutes)