Recruiting
Early Phase 1

C-Peptide

Sponsor:

University of Cincinnati

Code:

NCT06470295

Conditions

Hypoglycemia

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Saline

C-peptide

Study Details

Brief 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

Hypoglycemia

Type 1 Diabetes

Study ID

NCT06470295

Start date

Jun 1, 2024

Status verified date

Aug, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • BMI less than 30 kg/m2

Exclusion Criteria:

  • pregnant or lactating women cigarette smoking presence of HIV or hepatitis presence of cardiovascular disease presence of microvascular disease

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Healthy Control- Saline

Saline will be infused in healthy control subjects during insulin-induced hypoglycemia

active comparator: Healthy Control- C-peptide

C-peptide will be infused in healthy control subjects during insulin-induced hypoglycemia

placebo comparator: T1D- Saline

Saline will be infused in T1D subjects during insulin-induced hypoglycemia

active comparator: T1D- C-peptide

C-peptide will be infused in T1D subjects during insulin-induced hypoglycemia

Interventions

Saline

Normal saline will be infused during insulin-induced hypoglycemia

C-peptide

C-peptide will be infused during insulin-induced hypoglycemia

Primary outcome measure

  • Glucagon [ Time Frame: During procedure, up to 2.5 hours ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267-0547

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

Feb 17, 2026

Last verified

Aug, 2025

Keywords

  • glucagon
  • hepatic glucose production
  • C-peptide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-02-17.