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Fasting for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis of type 1 diabetes
Non-obese (BMI < or = to 30)
Must not have
Presence of cardiovascular or peripheral vascular disease
Presence of HIV or hepatitis (due to their deleterious effects on the liver)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure, up to 2.5 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how fasting affects insulin-induced hypoglycemia in people with type 1 diabetes, to see how it impacts their body's response.

Who is the study for?
This trial is for non-obese individuals with type 1 diabetes, who have a C-peptide negative status. It's open to all genders and ethnicities, provided they don't smoke or have complications like neuropathy, retinopathy, nephropathy, HIV/hepatitis, cardiovascular diseases or are on certain medications like steroids or beta-blockers.
What is being tested?
The study investigates how fasting affects the body's response to low blood sugar in people with type 1 diabetes. Participants will undergo periods of fasting and feeding to see how these states influence their hormonal and liver responses during insulin-induced hypoglycemia.
What are the potential side effects?
While not explicitly stated in the information given, potential side effects may include symptoms related to hypoglycemia such as dizziness, confusion, sweating, hunger and possibly fainting during the fasting intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 1 diabetes.
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My BMI is 30 or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart or blood vessel disease.
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I do not have HIV or hepatitis.
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I have nerve, eye, or kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure, up to 2.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure, up to 2.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glucagon
Glucose infusion rate
Hepatic glucose production
Secondary study objectives
Epinephrine
Peripheral glucose uptake
Other study objectives
Cortisol
Growth Hormone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: FeedingExperimental Treatment1 Intervention
Subjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.
Group II: FastingExperimental Treatment1 Intervention
Subjects will remain fasted prior to insulin-induced hypoglycemia.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
439 Previous Clinical Trials
638,738 Total Patients Enrolled

Media Library

Fasting Clinical Trial Eligibility Overview. Trial Name: NCT05973799 — N/A
Type 1 Diabetes Research Study Groups: Fasting, Feeding
Type 1 Diabetes Clinical Trial 2023: Fasting Highlights & Side Effects. Trial Name: NCT05973799 — N/A
Fasting 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973799 — N/A
~0 spots leftby Dec 2024
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