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Controls-high fructose for Hypoglycemia
Phase 1
Waitlist Available
Led By Jason Winnick, PhD
Research Sponsored by Jason Winnick
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 21-40 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
Study Summary
This trial will study how different doses of sugar given through a vein affects blood sugar levels and the hormones that are released in response to low blood sugar in people with and without type 1 diabetes.
Who is the study for?
This trial is for men and women aged 21-40, of any race or ethnicity, who are not obese (BMI <28 kg/m2). It's designed to include people with and without type 1 diabetes to study how liver sugar levels affect the body's response to low blood sugar.Check my eligibility
What is being tested?
The study tests the effects of various interventions like Low Fructose, Saline, Glucagon, Dextrose solution, High Fructose, Somatostatin, and Insulin on liver glycogen levels and hypoglycemia responses in humans. The goal is to understand better how these factors influence each other.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites due to insulin or glucagon administration. There might also be discomfort from low or high blood sugar levels caused by the interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epinephrine
Glucagon
Glucose Infusion Rate
Secondary outcome measures
Hepatic Glucose Production
Liver Glycogen
Peripheral Glucose Uptake
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Controls-high fructoseActive Control5 Interventions
A second group of control subjects will undergo a single metabolic study using a higher dose of fructose (6.5 mg/kg/min).
Group II: Controls-low fructoseActive Control5 Interventions
Each subject from Group 1 will undergo another metabolic study where fructose (1.3 mg/kg/min) is infused so as to stimulate liver glucose uptake and glycogen deposition.
Group III: Controls-salinePlacebo Group5 Interventions
Each subject from Group 1 will undergo a metabolic study where saline is infused so as to not stimulate liver glucose uptake and glycogen deposition.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Jason WinnickLead Sponsor
Jason Winnick, PhDPrincipal Investigator - University of Cincinnati
University of Cincinnati
2 Previous Clinical Trials
64 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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