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Recruiting NCT05973799

NCT05973799 Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

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Clinical Trial Summary
NCT ID NCT05973799
Status Recruiting
Phase
Sponsor University of Cincinnati
Condition Hypoglycemia
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2019-10-10
Primary Completion 2024-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 45 Years
Study Type INTERVENTIONAL
Interventions
FastingFeeding

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2019-10-10 with a primary completion date of 2024-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Jason Winnick, PhD

✉ jason.winnick@uc.edu

📞 513-558-4437

Frequently Asked Questions

Who can join the NCT05973799 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Hypoglycemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05973799 currently recruiting?

Yes, NCT05973799 is actively recruiting participants. Contact the research team at jason.winnick@uc.edu for enrollment information.

Where is the NCT05973799 trial being conducted?

This trial is being conducted at Cincinnati, United States.

Who is sponsoring the NCT05973799 clinical trial?

NCT05973799 is sponsored by University of Cincinnati. The trial plans to enroll 10 participants.

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