Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Cincinnati

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

males and females of any race or ethnicity

non-obese (BMI < or = to 30)

have a diagnosis of type 1 diabetes

C-peptide negative

Disqualifiers

pregnant women

cigarette smoking

Taking inflammation-targeting steroids (e.g., prednisone).

Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fasting

    Other intervention

    Subjects remain fasted prior to insulin-induced hypoglycemia.

  • Feeding

    Other intervention

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

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: FastingExperimental treatment 1 intervention
Group B: FeedingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Glucagon

From plasma

Time frame
During procedure, up to 2.5 hours
2

Hepatic glucose production

From plasma

Time frame
During procedure, up to 2.5 hours
3

Glucose infusion rate

Amount of glucose required to maintain glycemia at \~55 mg/dL.

Time frame
During procedure, up to 2.5 hours

Secondary outcomes

1

Epinephrine

From plasma

Time frame
During procedure, up to 2.5 hours
2

Peripheral glucose uptake

From plasma

Time frame
During procedure, up to 2.5 hours

Other outcomes

1

Cortisol

From plasma

Time frame
During procedure, up to 2.5 hours
2

Growth Hormone

From plasma

Time frame
During procedure, up to 2.5 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.