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NCT03241706Active, not recruitingPhase 1

Liver Glycogen and Hypoglycemia in Humans

Effect of Liver Glycogen Content on Hypoglycemic Counterregulation

Source: ClinicalTrials.gov · Last updated 25 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
40 (estimated)
First submitted
4 Aug 2017
Start date
2 Aug 2018
Primary completion date
31 May 2028
Lead sponsor
Jason Winnick
NCT number
NCT03241706

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 40
  • From 2 Aug 2018 to the primary completion date, 31 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking inflammation-targeting steroids (e.g., prednisone).
  • Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).

Other illness

  • The presence of cardiovascular or peripheral vascular disease.

Other

  • Pregnant women.
  • Cigarette smoking.
  • Abnormal hematocrit or electrolyte levels.
  • The presence of neuropathy, retinopathy or nephropathy.
  • Any metal in the body that would make magnetic resonance spectroscopy dangerous.

Who the study is looking for

  • Males and females of any race or ethnicity.
  • Aged 21-40 years.
  • Non-obese (BMI \<28 kg/m2).

Age in the registry: 21 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.