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

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ClinicalTrials.gov Identifier: NCT03034226
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hypoglycemia Diabetes Mellitus, Type 1 Other: Glucose clamp technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
Actual Study Start Date : February 23, 2017
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Active Comparator: Single episode of hypoglycemia
Day 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours
Other: Glucose clamp technique
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose

Active Comparator: Two episodes of hypoglycemia
Day 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours
Other: Glucose clamp technique
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034226


Locations
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Denmark
Department of Clinical Medicine
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Mads Bisgaard Bengtsen, MD, phd student Department of Endocrinology and Internal Medicine

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03034226     History of Changes
Other Study ID Numbers: Project 1-10-72-304-16
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Hypoglycemia-Associated Autonomic Failure (HAAF)
Additional relevant MeSH terms:
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Hypoglycemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs