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

2022-0236

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.

2024-06-01

2027-06-01

2028-01-01

Active (not recruiting)

Early phase I

38

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each subject will undergo two metabolic studies, one where they receive an IV infusion of C-peptide during insulin-induced hypoglycemia, and one where they will receive an IV infusion of saline instead.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'During participation in these studies, the subject and the researchers will not know which treatment (C-peptide versus saline) was administered to the subject on what day until after that subject has completed the study.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 38, 'type': 'ESTIMATED'}}

2024-06-24