Effect of C-peptide on Hypoglycemic Counterregulation

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT06470295
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Saline — OTHER
    Normal saline will be infused during insulin-induced hypoglycemia
  • C-peptide — BIOLOGICAL
    C-peptide will be infused during insulin-induced hypoglycemia

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Aug 2025
Primary completion
Jun 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45267-0547
Jason Winnick, PhD
[email protected]
513-558-4437
Natalie Whitsett
[email protected]

Find similar trials in Cincinnati, OH

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Cincinnati· Cincinnati, OH

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