Effect of Fasting on Insulin-induced Hypoglycemia Counterregulation in Healthy Humans

NCT04392843 | Completed

• 1 other identifier: 2018-0625
• Study Type: interventional
• Target: 12
• 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, we observed in dogs that liver glycogen content can be a determinant of hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, we will determine if nutritionally-manipulated changes in liver glycogen concentrations have an impact on hypoglycemic counterregulation in non-T1D control subjects.

Conditions

Hypoglycemia

Keywords

glucagon; hepatic glucose production; liver glycogen

Outcome Measures

Primary Outcomes (3)

• Glucagon

  From plasma

  During intervention

• Epinephrine

  From plasma

  During intervention

• Glucose infusion rate

  Required to clamp glucose at 50 mg/dL

  During intervention

Secondary Outcomes (2)

• Hepatic glucose production

  During intervention

• Peripheral glucose uptake

  During intervention

Study Arms (2)

Fasting

OTHER

Subjects will remain fasted prior to insulin-induced hypoglycemia.

Other: Fasting

Feeding

ACTIVE COMPARATOR

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: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females of any race or ethnicity.
• Aged 21-40 years.
• Fasting glucose lower than 110 mg/dL.
• Non-obese (BMI \<28 kg/m2).
• Otherwise healthy as determined by a physician (i.e., no acute or chronic conditions/ illnesses that might have an impact on the results of the study).

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 diagnosis of diabetes (type 1 or type 2) or 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

Location

Related Publications (1)

• Warner SO, Dai Y, Sheanon N, Yao MV, Cason RL, Arbabi S, Patel SB, Lindquist D, Winnick JJ. Short-term fasting lowers glucagon levels under euglycemic and hypoglycemic conditions in healthy humans. JCI Insight. 2023 Jun 22;8(12):e169789. doi: 10.1172/jci.insight.169789.

  PMID: 37166980 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: Assistant Professor

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

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 19, 2020
• Study Start: April 12, 2019
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)