Status:
COMPLETED
Effect of Fasting on Insulin-induced Hypoglycemia Counterregulation in Healthy Humans
Lead Sponsor:
University of Cincinnati
Conditions:
Hypoglycemia
Eligibility:
All Genders
21-40 years
Phase:
NA
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, we observed in dogs that liver glyco...
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-i...
Eligibility Criteria
Inclusion
- Males and females of any race or ethnicity.
- Aged 21-40 years.
- Fasting glucose lower than 110 mg/dL.
- Non-obese (BMI \<28 kg/m2).
- Otherwise healthy as determined by a physician (i.e., no acute or chronic conditions/ illnesses that might have an impact on the results of the study).
Exclusion
- 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 diagnosis of diabetes (type 1 or type 2) or 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.
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04392843
Start Date
April 12 2019
End Date
May 11 2023
Last Update
July 12 2023
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0547