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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

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date March 21, 2018
Actual Study Start Date  ICMJE February 23, 2017
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Insulin sensitivity [ Time Frame: Day 2 and day 4 (T=60 minutes - T=240 minutes) ]
Insulin sensitivity before, during hypoglycemia and in the next 4 hours 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
Change History Complete list of historical versions of study NCT03034226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects
Official Title  ICMJE A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Hypoglycemia
  • Diabetes Mellitus, Type 1
Intervention  ICMJE Other: Glucose clamp technique
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose
Study Arms  ICMJE
  • Active Comparator: Single episode of hypoglycemia
    Day 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours
    Intervention: Other: Glucose clamp technique
  • Active Comparator: Two episodes of hypoglycemia
    Day 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours
    Intervention: Other: Glucose clamp technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034226
Other Study ID Numbers  ICMJE Project 1-10-72-304-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mads Bisgaard Bengtsen, MD, phd student Department of Endocrinology and Internal Medicine
PRS Account University of Aarhus
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP