Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
38 participants
INTERVENTIONAL
2024-06-01
2028-01-01
Brief Summary
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Detailed Description
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Specific Aim #1 is to determine, in healthy control subjects, the effect of C-peptide co-infusion with insulin on endogenous glucose production (EGP) and counterregulatory hormone levels during hypoglycemia. This will be addressed by studying a single group of healthy subjects two times. In both studies, hypoglycemia will be induced with an intravenous (IV) infusion of insulin. During one study, C-peptide will be infused during the hypoglycemic period, and in the other study, saline will be infused. EGP is our primary variable, with secondary analyses including counterregulatory hormones and metabolic substrates.
Specific Aim #2 is to determine, in T1D patients, the effect of C-peptide co-infusion with insulin on EGP and counterregulatory hormone levels during hypoglycemia. The research plan for this Aim is very similar to that of Aim #1, with the main exception being that we will study T1D patients instead of healthy controls (e.g., two hypoglycemic clamp studies where C-peptide is administered during one study and saline during the other). In addition, the glycemic levels of these T1D patients will be monitored for 10 days prior to this visit to ensure that they do not experience hypoglycemia which could confound the data for the metabolic studies. Similar to Aim #1, EGP is our primary outcome variable, with secondary analyses including hormone and substrate levels.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Healthy Control- Saline
Saline will be infused in healthy control subjects during insulin-induced hypoglycemia
Saline
Normal saline will be infused during insulin-induced hypoglycemia
Healthy Control- C-peptide
C-peptide will be infused in healthy control subjects during insulin-induced hypoglycemia
C-peptide
C-peptide will be infused during insulin-induced hypoglycemia
T1D- Saline
Saline will be infused in T1D subjects during insulin-induced hypoglycemia
Saline
Normal saline will be infused during insulin-induced hypoglycemia
T1D- C-peptide
C-peptide will be infused in T1D subjects during insulin-induced hypoglycemia
C-peptide
C-peptide will be infused during insulin-induced hypoglycemia
Interventions
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Saline
Normal saline will be infused during insulin-induced hypoglycemia
C-peptide
C-peptide will be infused during insulin-induced hypoglycemia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Jason Winnick
Principal Investigator
Principal Investigators
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Jason Winnick, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Warner SO, Dai Y, Sheanon N, Yao MV, Cason RL, Arbabi S, Patel SB, Lindquist D, Winnick JJ. Short-term fasting lowers glucagon levels under euglycemic and hypoglycemic conditions in healthy humans. JCI Insight. 2023 Jun 22;8(12):e169789. doi: 10.1172/jci.insight.169789.
Related Links
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Link to published paper
Other Identifiers
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2022-0236
Identifier Type: -
Identifier Source: org_study_id
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