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Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes 10

Recruiting
Clinical Trial NCT05973799 is an interventional study for Hypoglycemia, Type1diabetes that is recruiting. It started on October 10, 2019 with plans to enroll 10 participants. Led by University of Cincinnati, it is expected to complete by December 31, 2024. The latest data from ClinicalTrials.gov was last updated on September 3, 2024.
Brief Summary
Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with T...Show More
Detailed Description
Because patients with type 1 diabetes (T1D) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. This often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. In addition to the difficulty estimating one's own insulin requirements after a meal, counterregulato...Show More
Official Title

Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Conditions
HypoglycemiaType1diabetes
Other Study IDs
  • 2019-0816
NCT ID Number
NCT05973799
Start Date (Actual)
2019-10-10
Last Update Posted
2024-09-03
Completion Date (Estimated)
2024-12-31
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
glucagon
hepatic glucose metabolism
liver glycogen
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFasting
Subjects will remain fasted prior to insulin-induced hypoglycemia.
Fasting
Subjects remain fasted prior to insulin-induced hypoglycemia.
ExperimentalFeeding
Subjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.
Feeding
Subjects eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glucagon
From plasma
During procedure, up to 2.5 hours
Hepatic glucose production
From plasma
During procedure, up to 2.5 hours
Glucose infusion rate
Amount of glucose required to maintain glycemia at \~55 mg/dL.
During procedure, up to 2.5 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Epinephrine
From plasma
During procedure, up to 2.5 hours
Peripheral glucose uptake
From plasma
During procedure, up to 2.5 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • males and females of any race or ethnicity
  • non-obese (BMI < or = to 30)
  • have a diagnosis of type 1 diabetes
  • C-peptide negative

  • pregnant women
  • cigarette smoking
  • Taking inflammation-targeting steroids (e.g., prednisone).
  • Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).
  • Hematocrit less than 33%.
  • Presence of HIV or hepatitis (due to their deleterious effects on the liver).
  • The presence of cardiovascular or peripheral vascular disease.
  • The presence of neuropathy, retinopathy or nephropathy.
  • A detection of the presence of any other disease or condition by one of the study doctors, that would be expected to confound the responses to insulin-induced hypoglycemia or make participation in the study dangerous to the individual.
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Study Responsible Party
Jason Winnick, Principal Investigator, Principal Investigator, University of Cincinnati
Study Central Contact
Contact: Jason Winnick, PhD, 513-558-4437, [email protected]
Contact: Alyssa Randolph, 513-558-3427, [email protected]
1 Study Locations in 1 Countries

Ohio

University of Cincinnati, Cincinnati, Ohio, 45267-0547, United States
Jason Winnick, PhD, Contact, 513-558-4437, [email protected]
Recruiting