C-peptide's effect on blood sugar regulation during hypoglycemia
On the Regulation of Hepatic Glucose Metabolism During Insulin-induced Hypoglycemia
This study tests if adding C-peptide to insulin can help people with type 1 diabetes and healthy individuals better manage their blood sugar during low blood sugar episodes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06470295 on ClinicalTrials.gov |
What this trial studies
This study investigates how C-peptide influences glucagon secretion and hepatic glucose production during insulin-induced hypoglycemia in individuals with type 1 diabetes (T1D) and healthy controls. The research involves administering C-peptide alongside insulin to assess its impact on counterregulatory hormone levels and endogenous glucose production. Two separate hypoglycemic clamp studies will be conducted: one with healthy subjects and another with T1D patients, comparing the effects of C-peptide infusion to saline. The goal is to better understand the potential benefits of C-peptide in managing hypoglycemia in T1D.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 1 diabetes and healthy adults with a BMI less than 30 kg/m2.
Not a fit: Patients who are pregnant, lactating, smokers, or have cardiovascular or microvascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypoglycemia in patients with type 1 diabetes.
How similar studies have performed: Previous studies in animal models have shown promising results with C-peptide, but this approach is novel in human subjects.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jason Winnick, PhD — University of Cincinnati
- Study coordinator: Jason Winnick, PhD
- Email: jason.winnick@uc.edu
- Phone: 513-558-4437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.