Short-term fasting lowers glucagon levels under euglycemic and hypoglycemic conditions in healthy humans.
Shana O Warner, Yufei Dai, Nicole Sheanon...
https://pubmed.ncbi.nlm.nih.gov/37166980/Actively Recruiting
Led by University of Cincinnati · Updated on 2026-02-17
38
Participants Needed
1
Research Sites
30 weeks
Total Duration
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
Effect of C-peptide on Hypoglycemic Counterregulation
J
Jason Winnick, PhD
N
Natalie Whitsett
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University of Cincinnati
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | C-peptide (during insulin-induced hypoglycemia) | Saline (during insulin-induced hypoglycemia) |
|---|---|---|
| What is it? | C-peptide is infused during insulin-induced hypoglycemia to study its effect on counterregulatory hormone responses. | Saline is infused during insulin-induced hypoglycemia, acting as a placebo comparator within the crossover design. |
| Role in the trial | Serves as the investigational intervention evaluating the effect of C-peptide on hormonal counterregulation. | Functions as the placebo control infusion to establish baseline physiological response. |
| Primary use or purpose | Studied to determine whether C-peptide alters the body's hormonal responses during hypoglycemic episodes in healthy or T1D participants. | Used as a reference intervention to measure baseline hormonal responses without C-peptide influence during hypoglycemia. |
| How is it given or performed? | C-peptide is delivered via intravenous infusion during an insulin-induced hypoglycemic clamp procedure. | Normal saline is administered intravenously during the same hypoglycemic clamp procedure for comparison. |
| Evidence status | Ongoing clinical investigation; results from this trial are not yet available. Previous research highlights the importance of glucagon response in hypoglycemia, but C-peptide's role in counterregulation remains under study. | Baseline saline infusion has established roles in physiological studies. Glucagon levels and hepatic glucose response under hypoglycemic conditions are measurable, as supported by published evidence in healthy adults. |
| Important limitations | The study uses a small controlled population and short monitoring period, so findings may not generalize to everyday clinical care or broader diabetic populations. Results pending. | Saline infusion represents only a physiological baseline, not a therapeutic intervention for hypoglycemia. Results from healthy controls may differ from those in type 1 diabetes. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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Shana O Warner, Yufei Dai, Nicole Sheanon...
https://pubmed.ncbi.nlm.nih.gov/37166980/University of Cincinnati
Lead Sponsor