Clinical trial NCT03034226: Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects
Official title: A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Diabetes Mellitus, Type 1
Keywords: Hypoglycemia-Associated Autonomic Failure (HAAF)
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Day 2 and day 4 (T=60 minutes - T=240 minutes)
Secondary outcomes:
measure: Hormonal counter regulatory response to hypoglycemia
timeFrame: 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
measure: Symptoms during hypoglycemia
timeFrame: Day 2 and day 4 (T=0 minutes - T=420 minutes)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Medicine
Study officials:
affiliation: Department of Endocrinology and Internal Medicine
name: Mads Bisgaard Bengtsen, MD, phd student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bengtsen MB, Stoy J, Rittig NF, Voss TS, Magnusson NE, Svart MV, Jessen N, Moller N. A Human Randomized Controlled Trial Comparing Metabolic Responses to Single and Repeated Hypoglycemia in Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa645. doi: 10.1210/clinem/dgaa645.