Recruiting

Fasting

Sponsor:

University of Cincinnati

Code:

NCT05973799

Conditions

Hypoglycemia

Type1diabetes

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Fasting

Feeding

Study Details

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 T1D will be determined.

Conditions

Hypoglycemia

Type1diabetes

Study ID

NCT05973799

Start date

Oct 10, 2019

Status verified date

Aug, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • males and females of any race or ethnicity
  • non-obese (BMI < or = to 30)
  • have a diagnosis of type 1 diabetes
  • C-peptide negative

Exclusion Criteria:

  • 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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Fasting

Subjects will remain fasted prior to insulin-induced hypoglycemia.

experimental: Feeding

Subjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.

Interventions

Fasting

Subjects remain fasted prior to insulin-induced hypoglycemia.

Feeding

Subjects eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.

Primary outcome measure

  • Glucagon [ Time Frame: During procedure, up to 2.5 hours ]
  • Hepatic glucose production [ Time Frame: During procedure, up to 2.5 hours ]
  • Glucose infusion rate [ Time Frame: During procedure, up to 2.5 hours ]

Central Contacts and Locations

Central contacts

Jason Winnick, PhD

513-558-4437jason.winnick@uc.edu

Alyssa Randolph

513-558-3427Randolas@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267-0547

Contacts

Jason Winnick, PhD

513-558-4437jason.winnick@uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Sep 3, 2024

Last verified

Aug, 2024

Keywords

  • glucagon
  • hepatic glucose metabolism
  • liver glycogen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2024-09-03.