Impact of Fasting on Low Blood Sugar Responses in Type 1 Diabetes
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
This study is testing how fasting affects the body’s response to low blood sugar in people with type 1 diabetes to see if it makes managing their condition harder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05973799 on ClinicalTrials.gov |
What this trial studies
This study investigates how fasting affects the body's hormonal and liver responses to insulin-induced hypoglycemia in individuals with type 1 diabetes (T1D). Participants will undergo two trials: one after eating a controlled breakfast and lunch, and another after fasting. The goal is to understand whether fasting diminishes the body's ability to counteract low blood sugar levels, which is a significant challenge for T1D management. By examining these responses, the study aims to identify potential strategies to improve glycemic control in T1D patients.
Who should consider this trial
Good fit: Ideal candidates are non-obese individuals diagnosed with type 1 diabetes who are C-peptide negative.
Not a fit: Patients who are pregnant, smoke, or have other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing hypoglycemia in patients with type 1 diabetes.
How similar studies have performed: Previous studies have indicated that fasting can negatively impact hormonal responses to hypoglycemia, suggesting that this approach is novel and may provide new insights into T1D management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Jason Winnick, PhD
- Email: jason.winnick@uc.edu
- Phone: 513-558-4437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.