Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

NCT05973799 | Recruiting

• 1 other identifier: 2019-0816
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia; Type1diabetes

Keywords

glucagon; hepatic glucose metabolism; liver glycogen

Outcome Measures

Primary Outcomes (3)

• Glucagon

  From plasma

  During procedure, up to 2.5 hours

• Hepatic glucose production

  From plasma

  During procedure, up to 2.5 hours

• Glucose infusion rate

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

  During procedure, up to 2.5 hours

Secondary Outcomes (2)

• Epinephrine

  During procedure, up to 2.5 hours

• Peripheral glucose uptake

  During procedure, up to 2.5 hours

Other Outcomes (2)

• Cortisol

  During procedure, up to 2.5 hours

• Growth Hormone

  During procedure, up to 2.5 hours

Study Arms (2)

Fasting

EXPERIMENTAL

Subjects will remain fasted prior to insulin-induced hypoglycemia.

Other: Fasting

Feeding

EXPERIMENTAL

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

Other: Feeding

Interventions

Fasting OTHER

Subjects remain fasted prior to insulin-induced hypoglycemia.

Fasting

Feeding OTHER

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

Feeding

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0547, United States

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jason Winnick, PhD

CONTACT

513-558-4437; jason.winnick@uc.edu

Alyssa Randolph

CONTACT

513-558-3427; Randolas@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each subject will undergo two metabolic studies, one after having remained fasted and one after having eaten breakfast and lunch.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 3, 2023
• Study Start: October 10, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)