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

NCT03034226 | Completed DMC

• 1 other identifier: Project 1-10-72-304-16
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Keywords

Hypoglycemia-Associated Autonomic Failure (HAAF)

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  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 Outcomes (2)

• Hormonal counter regulatory response to hypoglycemia

  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

  Day 2 and day 4 (T=0 minutes - T=420 minutes)

Study Arms (2)

Single episode of hypoglycemia

ACTIVE COMPARATOR

Day 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours

Other: Glucose clamp technique

Two episodes of hypoglycemia

ACTIVE COMPARATOR

Day 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours

Other: Glucose clamp technique

Interventions

Glucose clamp technique OTHER

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

Single episode of hypoglycemia; Two episodes of hypoglycemia

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• More than 5 years of disease duration
• HbA1c 42-86 mmol/L
• No known HAAF
• BMI 22-28
• Written consent

You may not qualify if:

• 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
• BMI 22-28
• Written consent
• Diseases f.x diabetes, epilepsy, ischemic heart disease or heart rhythm disturbance
• Medication f.x beta-blockade, steroids, psychotropics
• Smoking
• Drug abuse

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Clinical Medicine

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32927476 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mads Bisgaard Bengtsen, MD, phd student

  Department of Endocrinology and Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 27, 2017
• Study Start: February 23, 2017
• Primary Completion: February 1, 2018
• Study Completion: January 1, 2019
• Last Updated: October 5, 2022

Record last verified: 2018-03

Locations

DK (1)