Actively Recruiting

Early Phase 1
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID06470295

On the Regulation of Hepatic Glucose Metabolism During Insulin-induced Hypoglycemia

Led by University of Cincinnati · Updated on 2026-02-17

38

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Iatrogenic hypoglycemia is a major challenge in managing blood sugar safely and effectively in people with type 1 diabetes. This happens because during insulin-induced hypoglycemia, glucagon secretion is reduced, which lowers liver glucose production and worsens hypoglycemic episodes. Researchers have found that the natural protein C-peptide increases glucagon secretion in dogs during insulin-induced hypoglycemia, and this study aims to explore if the same effect happens in humans with and without type 1 diabetes. The study involves two main groups: healthy control subjects and people with type 1 diabetes. Each participant will undergo two separate hypoglycemia tests where insulin is infused intravenously to cause low blood sugar. During one test, C-peptide will be infused along with insulin, and during the other, saline will be infused instead. For participants with type 1 diabetes, their blood sugar levels will be monitored for 10 days before testing to ensure no recent hypoglycemia. Researchers will compare the effects of C-peptide and saline on liver glucose production and hormone levels during these tests. Participants will be closely observed during the hypoglycemia procedures lasting up to 2.5 hours, with measurements of glucagon and hepatic glucose production as key outcomes. Liver glycogen levels will be assessed before insulin-induced hypoglycemia. The study uses a randomized, double-blind design where neither participants nor researchers know whether C-peptide or saline is being given during each test. Overall, the study will help understand how C-peptide affects glucose regulation during hypoglycemia in humans, lasting from initial screening through the testing visits.

CONDITIONS

Brief Title

Effect of C-peptide on Hypoglycemic Counterregulation

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) less than 30 kg/m2
  • Adults aged between 18 and 40 years
  • Healthy volunteers and individuals with type 1 diabetes
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Cigarette smokers
  • Presence of HIV or hepatitis
  • Presence of cardiovascular disease
  • Presence of microvascular disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - 10 days

Participants with type 1 diabetes will have their blood glucose levels monitored for 10 days prior to the study visits to ensure no hypoglycemia occurs that could affect the study results.

Daily monitoring visits or remote glucose checks

Treatment

Duration - Up to 2.5 hours per procedure

Participants undergo two hypoglycemic clamp studies where insulin is infused to induce hypoglycemia. During one study, C-peptide is infused, and during the other, saline is infused. These studies assess glucose metabolism and hormone responses.

2 separate in-person study visits for hypoglycemic clamp procedures

Trial Site Locations

Total: 1 location

1

University of Cincinnati

Cincinnati, Ohio, United States, 45267-0547

Actively Recruiting

Loading map...

Research Team

J

Jason Winnick, PhD

N

Natalie Whitsett

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

Similar Trials

Impact of Sexual Activity on Hypoglycemia Risk in Adults Wit...

Type 1 Diabetes (T1D)

Actively Recruiting

1 location

Fully Closed-Loop Glucose Control in Adults With Type 1 Diab...

Type 1 Diabetes

Actively Recruiting

4 locations

TEPLIzumab: Quality of Life Evaluation During Stage Transiti...

Type 1 Diabetes

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial