Fasting for Type 1 Diabetes

Overseen By Alyssa Randolph

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Must not be taking: Steroids, Beta-blockers

Disqualifiers: Pregnancy, Smoking, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My gender or race does not limit my participation.

I have been diagnosed with type 1 diabetes.

You do not produce C-peptide.

Exclusion Criteria

I have heart or blood vessel disease.

I do not have HIV or hepatitis.

I am currently taking medication for heart or lung issues, like beta-blockers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial 1: Feeding

Participants eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge

1 day

1 visit (in-person)

Trial 2: Fasting

Participants remain fasted prior to an insulin-induced hypoglycemic challenge

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the hypoglycemic challenges

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fasting
• Feeding

Trial Overview 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.

How Is the Trial Designed?

Group I: Feeding Experimental Treatment 1 Intervention

Subjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.

Group II: Fasting Experimental Treatment 1 Intervention

Subjects will remain fasted prior to insulin-induced hypoglycemia.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+