Clinical trial

Effect of Liver Glycogen Content on Hypoglycemic Counterregulation

Name
2016-7982
Description
The purpose of this research study is to learn more about how sugar levels in the liver affect the ability of people both with and without type 1 diabetes. People with type 1 diabetes do not make their own insulin, and are therefore required to give themselves injections of insulin in order to keep their blood sugar under control. However, very often people with type 1 diabetes give themselves too much insulin and this causes their blood sugar to become very low, which can have a negative impact on their health. When the blood sugar becomes low, healthy people secrete hormones such as glucagon and epinephrine (i.e., adrenaline), which restore the blood sugar levels to normal by increasing liver glucose production into the blood. However, in people with type 1 diabetes, the ability to release glucagon and epinephrine is impaired and this reduces the amount of sugar the liver is able to release. People with type 1 diabetes also have unusually low stores of sugar in their livers. It has been shown in animal studies that when the amount of sugar stored in the liver is increased, it increases the release of glucagon and epinephrine during insulin-induced hypoglycemia. In turn, this increase in hormone release boosts liver sugar production. However, it is not known if increased liver sugar content can influence these responses in people with and without type 1 diabetes. In addition, when people with type 1 diabetes do experience an episode of low blood sugar, it impairs their responses to low blood sugar the next day. It is also unknown whether this reduction in low blood sugar responses is caused by low liver sugar levels. The investigators want to learn more about how liver sugar levels affect the ability to respond to low blood sugar.
Trial arms
Trial start
2018-08-02
Estimated PCD
2025-05-31
Trial end
2025-05-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Low Fructose
IV fructose (1.3 mg/kg/min)
Arms:
Controls-high fructose
Saline
Saline given as a comparison to fructose.
Arms:
Controls-saline
Somatostatin
IV infusion of somatostatin (60 ng/kg/min)
Arms:
Controls-high fructose, Controls-low fructose, Controls-saline
Other names:
SRIF
Insulin
IV infusion of insulin between 20-60 mU/m2/min.
Arms:
Controls-high fructose, Controls-low fructose, Controls-saline
Glucagon
IV glucagon (0.65 ng/kg/min).
Arms:
Controls-high fructose, Controls-low fructose, Controls-saline
Dextrose solution
IV dextrose to clamp the plasma glucose at the desired level.
Arms:
Controls-high fructose, Controls-low fructose, Controls-saline
Other names:
d20
High Fructose
IV-fructose (6.5 mg/kg/min)
Arms:
Controls-low fructose
Size
40
Primary endpoint
Epinephrine
2 hours
Glucagon
2 hours
Glucose Infusion Rate
2 hours
Eligibility criteria
Inclusion Criteria: * Males and females of any race or ethnicity. * Aged 21-40 years. * Non-obese (BMI \<28 kg/m2). Exclusion Criteria: * Pregnant women. * Cigarette smoking. * Taking inflammation-targeting steroids (e.g., prednisone). * Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators). * Abnormal hematocrit or electrolyte levels. * The presence of cardiovascular or peripheral vascular disease. * The presence of neuropathy, retinopathy or nephropathy. * Any metal in the body that would make magnetic resonance spectroscopy dangerous.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The subjects will not be informed which treatment they will receive for a given trial.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-02-28

1 organization

6 products

1 drug

1 indication

Organization
Jason Winnick
Indication
Hypoglycemia
Product
Insulin
Product
Glucagon
Product
Dextrose