Effect of C-peptide on Hypoglycemic Counterregulation

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Cincinnati

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI less than 30 kg/m2

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Saline

    Other intervention

    Normal saline will be infused during insulin-induced hypoglycemia

  • C-peptide

    Biological/Vaccine

    C-peptide will be infused during insulin-induced hypoglycemia

Treatment groups

38 Participants
are divided into 4 treatment groups
Group A: Healthy Control- SalinePlacebo comparator 1 intervention
Group B: Healthy Control- C-peptideActive comparator 1 intervention
Group C: T1D- SalinePlacebo comparator 1 intervention
Group D: T1D- C-peptideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glucagon

from plasma

Time frame
During procedure, up to 2.5 hours

Secondary outcomes

1

Hepatic glucose production

from plasma

Time frame
During procedure, up to 2.5 hours
2

Liver glycogen

from MRS measurement

Time frame
Prior to insulin-induced hypoglycemia

Other outcomes

Sponsors and contacts

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