Effect of C-peptide on Hypoglycemic Counterregulation
NCT06470295 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2026-02-17
Summary
Iatrogenic hypoglycemia is the most prominent barrier to the safe, effective management of blood sugar in people with type 1 diabetes due to periodic over-insulinization. During insulin-induced hypoglycemia, glucagon secretion is diminished in type 1 diabetes which, in turn, reduces hepatic glucose production and increases the depth and duration of hypoglycemic episodes. We have observed that the naturally occurring protein C-peptide increases glucagon secretion in dogs during insulin-induced hypoglycemia, which increases hepatic glucose production; the experiments in this application will shed light on the translation of this finding to the human.
Conditions
Interventions
- OTHER
-
Saline
Normal saline will be infused during insulin-induced hypoglycemia
- BIOLOGICAL
-
C-peptide
C-peptide will be infused during insulin-induced hypoglycemia
Sponsors & Collaborators
-
University of Cincinnati
lead OTHER
Principal Investigators
-
Jason Winnick, PhD · University of Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2027-06-01
- Completion
- 2028-01-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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