Actively Recruiting
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
Led by University of Cincinnati · Updated on 2024-09-03
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how fasting affects the body's hormonal and liver responses to insulin-induced low blood sugar (hypoglycemia) in people with type 1 diabetes (T1D). This condition is challenging because patients often overestimate their insulin needs, leading to dangerous low blood sugar episodes. The study aims to better understand how fasting might change the body's natural defenses against these episodes, which are weakened in T1D. Participants will take part in two separate trials: one where they eat a normal breakfast and lunch before a controlled insulin-induced hypoglycemia test, and another where they remain fasted before the test. This comparison will show how fasting versus eating influences hormonal responses and liver glucose production during low blood sugar. During the study visits, participants will undergo insulin-induced hypoglycemia while researchers measure hormones like glucagon and epinephrine, liver glucose production, and glucose infusion rates over about 2.5 hours. These tests will help assess how the body counters low blood sugar under different eating conditions. The entire study includes careful monitoring to ensure safety and accurate measurement of these responses.
CONDITIONS
Brief Title
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females of any race or ethnicity
- Non-obese with a body mass index (BMI) of 30 or less
- Diagnosed with type 1 diabetes
- C-peptide negative
You will not qualify if you...
- Pregnant women
- Cigarette smokers
- Taking inflammation-targeting steroids such as prednisone
- Taking medications that affect adrenergic signaling like beta-blockers or bronchodilators
- Hematocrit less than 33%
- Presence of HIV or hepatitis
- Having cardiovascular or peripheral vascular disease
- Having neuropathy, retinopathy, or nephropathy
- Any other disease or condition that may affect responses to insulin-induced hypoglycemia or make participation unsafe as determined by study doctors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2.5 hours per trial
Participants undergo two experimental trials to assess the effect of fasting versus feeding on insulin-induced hypoglycemia. One trial involves eating an isocaloric breakfast and lunch prior to the hypoglycemic challenge, and the other requires participants to remain fasted prior to the challenge.
2 visits (in-person), one for each trial condition
Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0547
Actively Recruiting
Research Team
J
Jason Winnick, PhD
A
Alyssa Randolph
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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