Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Hypoglycemia Clinical Trial

Official title:

Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973799
• Other study ID #: 2019-0816
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: University of Cincinnati
• Contact: Jason Winnick, PhD
• Phone: 513-558-4437
• Email: jason.winnick[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• type1diabetes

Intervention

Other:
• Fasting
Subjects remain fasted prior to insulin-induced hypoglycemia.
• Feeding
Subjects eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol	From plasma	During procedure, up to 2.5 hours
Other	Growth Hormone	From plasma	During procedure, up to 2.5 hours
Primary	Glucagon	From plasma	During procedure, up to 2.5 hours
Primary	Hepatic glucose production	From plasma	During procedure, up to 2.5 hours
Primary	Glucose infusion rate	Amount of glucose required to maintain glycemia at ~55 mg/dL.	During procedure, up to 2.5 hours
Secondary	Epinephrine	From plasma	During procedure, up to 2.5 hours
Secondary	Peripheral glucose uptake	From plasma	During procedure, up to 2.5 hours