Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

NCT ID: NCT05973799

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

Because patients with type 1 diabetes (T1D) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. This often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. In addition to the difficulty estimating one's own insulin requirements after a meal, counterregulatory hormone responses to hypoglycemia are impaired in patients with T1D, thereby reducing hepatic glucose production (HGP) and increasing the depth and duration of the hypoglycemic episode.

The discovery of ways by which counterregulatory responses to hypoglycemia can be improved in people with T1D is a priority. In previous experiments, it was observed that fasting reduces counterregulatory hormone secretion in healthy humans during insulin-induced hypoglycemia, thereby reducing hepatic glucose production (HGP). Therefore, the studies proposed herein will determine the effect of fasting on hypoglycemic counterregulation in people with T1D. It is hypothesized that fasting will diminish the hormonal and hepatic responses to insulin-induced hypoglycemia.

Each subject will undergo two trials; one where they eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge and a second one during which they remain fasted prior to the hypoglycemic challenge. This study design will allow assessment of the relationship between fasting and the counterregulatory responses to insulin-induced hypoglycemia in a population that is particularly vulnerable to low blood sugar.

Conditions

Hypoglycemia; Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fasting

Subjects will remain fasted prior to insulin-induced hypoglycemia.

Group Type: EXPERIMENTAL

Fasting

Intervention Type: OTHER

Subjects remain fasted prior to insulin-induced hypoglycemia.

Feeding

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

Group Type: EXPERIMENTAL

Feeding

Intervention Type: OTHER

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

Interventions

Fasting

Subjects remain fasted prior to insulin-induced hypoglycemia.

Intervention Type: OTHER

Feeding

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• males and females of any race or ethnicity
• non-obese (BMI < or = to 30)
• have a diagnosis of type 1 diabetes
• C-peptide negative

Exclusion Criteria

• pregnant women
• cigarette smoking
• Taking inflammation-targeting steroids (e.g., prednisone).
• Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).
• Hematocrit less than 33%.
• Presence of HIV or hepatitis (due to their deleterious effects on the liver).
• The presence of cardiovascular or peripheral vascular disease.
• The presence of neuropathy, retinopathy or nephropathy.
• A detection of the presence of any other disease or condition by one of the study doctors, that would be expected to confound the responses to insulin-induced hypoglycemia or make participation in the study dangerous to the individual.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Jason Winnick

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason Winnick, PhD

Role: CONTACT

jason.winnick@uc.edu

513-558-4437

Alyssa Randolph

Role: CONTACT

Randolas@ucmail.uc.edu

513-558-3427

Facility Contacts

Jason Winnick, PhD

Role: primary

jason.winnick@uc.edu

513-558-4437

Other Identifiers

2019-0816

Identifier Type: -

Identifier Source: org_study_id