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Completed

NCT Number: NCT03034226

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

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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Key information

Conditions

Hypoglycemia Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Medicine

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose clamp technique

Other

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

Primary outcomes

  1. Insulin sensitivity

    Time frame: 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 outcomes

  1. Hormonal counter regulatory response to hypoglycemia

    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

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

  2. Symptoms during hypoglycemia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 27, 2017
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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