- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03034226
Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects
October 4, 2022 updated by: University of Aarhus
A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Department of Clinical Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 2 and day 4 (T=60 minutes - T=240 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
Day 2 and day 4 (T=0 minutes - T=420 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mads Bisgaard Bengtsen, MD, phd student, Department of Endocrinology and Internal Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2017
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
January 17, 2017
First Submitted That Met QC Criteria
January 25, 2017
First Posted (Estimate)
January 27, 2017
Study Record Updates
Last Update Posted (Actual)
October 5, 2022
Last Update Submitted That Met QC Criteria
October 4, 2022
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project 1-10-72-304-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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