Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-30 @ 5:56 PM
Study NCT ID:
NCT06470295
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of C-peptide on Hypoglycemic Counterregulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002096', 'term': 'C-Peptide'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], '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.'}, 'primaryPurpose': 'BASIC_SCIENCE', '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucagon', 'timeFrame': 'During procedure, up to 2.5 hours', 'description': 'from plasma'}], 'secondaryOutcomes': [{'measure': 'Hepatic glucose production', 'timeFrame': 'During procedure, up to 2.5 hours', 'description': 'from plasma'}, {'measure': 'Liver glycogen', 'timeFrame': 'Prior to insulin-induced hypoglycemia', 'description': 'from MRS measurement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucagon', 'hepatic glucose production', 'C-peptide'], 'conditions': ['Hypoglycemia', 'Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37166980', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/37166980/', 'label': 'Link to published paper'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Iatrogenic hypoglycemia is recognized as a primary barrier to the safe, effective management of blood glucose in people with type 1 diabetes (T1D). In previous experiments in the dog, we observed that C-peptide infusion augmented glucagon secretion and hepatic glucose production during insulin-induced hypoglycemia. The proposed experiments will determine the translational impact of this finding in patients with and without T1D.\n\nSpecific 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.\n\nSpecific 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI less than 30 kg/m2\n\nExclusion Criteria:\n\n* pregnant or lactating women cigarette smoking presence of HIV or hepatitis presence of cardiovascular disease presence of microvascular disease'}, 'identificationModule': {'nctId': 'NCT06470295', 'briefTitle': 'Effect of C-peptide on Hypoglycemic Counterregulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'On the Regulation of Hepatic Glucose Metabolism During Insulin-induced Hypoglycemia', 'orgStudyIdInfo': {'id': '2022-0236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy Control- Saline', 'description': 'Saline will be infused in healthy control subjects during insulin-induced hypoglycemia', 'interventionNames': ['Other: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Control- C-peptide', 'description': 'C-peptide will be infused in healthy control subjects during insulin-induced hypoglycemia', 'interventionNames': ['Biological: C-peptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'T1D- Saline', 'description': 'Saline will be infused in T1D subjects during insulin-induced hypoglycemia', 'interventionNames': ['Other: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'T1D- C-peptide', 'description': 'C-peptide will be infused in T1D subjects during insulin-induced hypoglycemia', 'interventionNames': ['Biological: C-peptide']}], 'interventions': [{'name': 'Saline', 'type': 'OTHER', 'description': 'Normal saline will be infused during insulin-induced hypoglycemia', 'armGroupLabels': ['Healthy Control- Saline', 'T1D- Saline']}, {'name': 'C-peptide', 'type': 'BIOLOGICAL', 'description': 'C-peptide will be infused during insulin-induced hypoglycemia', 'armGroupLabels': ['Healthy Control- C-peptide', 'T1D- C-peptide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267-0547', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Winnick, PhD', 'role': 'CONTACT', 'email': 'jason.winnick@uc.edu', 'phone': '513-558-4437'}, {'name': 'Natalie Whitsett', 'role': 'CONTACT', 'email': 'whitsenh@ucmail.uc.edu'}], 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Jason Winnick, PhD', 'role': 'CONTACT', 'email': 'jason.winnick@uc.edu', 'phone': '513-558-4437'}, {'name': 'Natalie Whitsett', 'role': 'CONTACT', 'email': 'whitsenh@ucmail.uc.edu', 'phone': '513-558-4489'}], 'overallOfficials': [{'name': 'Jason Winnick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jason Winnick', 'investigatorAffiliation': 'University of Cincinnati'}}}}