Sugar Doses for Low Blood Sugar

Overseen By Jason Winnick, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jason Winnick

Must not be taking: Steroids, Beta-blockers, Bronchodilators

Disqualifiers: Pregnancy, Smoking, Cardiovascular disease, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how sugar levels in the liver affect the body's response to low blood sugar, particularly in individuals with and without type 1 diabetes. Researchers will test different sugar doses to determine if they can enhance the release of hormones that raise blood sugar levels. Participants will receive treatments involving either fructose or a placebo to assess their impact on liver sugar levels. This study is ideal for adults aged 21-40 who are not obese, have type 1 diabetes, and frequently experience low blood sugar episodes. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically inflammation-targeting steroids and medications that affect adrenergic signaling, like beta-blockers and bronchodilators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that increasing the amount of stored sugar in the liver, known as liver glycogen, can help the body respond better to low blood sugar. Studies have found that raising liver glycogen levels by 75% above normal improves how the body manages drops in blood sugar by enhancing hormonal responses. This approach appears well-tolerated because it involves adjusting sugar levels that the body naturally manages. In the reviewed studies, no serious side effects have been reported with this treatment. However, it is important to remember that this is early-stage research, and safety continues to be closely monitored in trials like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how manipulating liver glycogen could help manage low blood sugar, presenting a potentially new strategy for treatment. Unlike typical methods that rely on glucose or glucagon administration, this approach uses fructose in varying doses to stimulate liver glucose uptake and glycogen storage. By understanding these mechanisms, the trial aims to uncover faster or more efficient ways to stabilize blood sugar levels, potentially offering a novel and more effective solution for individuals experiencing hypoglycemia.

What evidence suggests that this trial's treatments could be effective for low blood sugar?

This trial will compare different methods of liver glycogen manipulation to manage low blood sugar. Research has shown that increasing liver glycogen, which is stored sugar, can help the body respond better to low blood sugar. Studies have found that raising liver glycogen levels by 75% improves the body's hormonal reactions needed to address low blood sugar. This is especially important for people with type 1 diabetes, who often have less liver glycogen and weaker hormone responses. By boosting liver glycogen, the body can more effectively release hormones like glucagon and epinephrine, which help increase blood sugar levels. These findings suggest that adjusting liver glycogen might be a useful way to manage low blood sugar. ^{1 3 5 6 7}

Who Is on the Research Team?

Jason Winnick, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for men and women aged 21-40, of any race or ethnicity, who are not obese (BMI <28 kg/m2). It's designed to include people with and without type 1 diabetes to study how liver sugar levels affect the body's response to low blood sugar.

Inclusion Criteria

My gender or race does not limit my participation.

Non-obese (BMI <28 kg/m2)

I am between 21 and 40 years old.

Exclusion Criteria

I am currently taking steroids for inflammation.

I have heart or blood vessel disease.

I have nerve, eye, or kidney damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Metabolic Study

Participants undergo metabolic studies with different infusions (saline, low fructose, high fructose) to assess liver glucose uptake and glycogen deposition

2 hours per session

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the metabolic studies

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liver Glycogen Manipulation

Trial Overview The study tests the effects of various interventions like Low Fructose, Saline, Glucagon, Dextrose solution, High Fructose, Somatostatin, and Insulin on liver glycogen levels and hypoglycemia responses in humans. The goal is to understand better how these factors influence each other.

How Is the Trial Designed?

Group I: Controls-high fructose Active Control 5 Interventions

A second group of control subjects will undergo a single metabolic study using a higher dose of fructose (6.5 mg/kg/min).

Group II: Controls-low fructose Active Control 5 Interventions

Each subject from Group 1 will undergo another metabolic study where fructose (1.3 mg/kg/min) is infused so as to stimulate liver glucose uptake and glycogen deposition.

Group III: Controls-saline Placebo Group 5 Interventions

Each subject from Group 1 will undergo a metabolic study where saline is infused so as to not stimulate liver glucose uptake and glycogen deposition.

Who Is Running the Clinical Trial?

Jason Winnick

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8424545/

Liver glycogen-induced enhancements in hypoglycemic ... Our data confirm that increasing liver glycogen content 75% above fasting levels enhances hormonal responses to insulin-induced hypoglycemia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4887181/

Hepatic glycogen can regulate hypoglycemic ... Liver glycogen is important for the counterregulation of hypoglycemia and is reduced in individuals with type 1 diabetes (T1D).

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03241706/liver-glycogen-and-hypoglycemia-in-humans

Liver Glycogen and Hypoglycemia in Humans The proposed experiments will improve our understanding of the mechanisms by which increased glycogen improves hypoglycemic counterregulation.

4. journals.physiology.org journals.physiology.org/doi/prev/20210329-aop/pdf/10.1152/ajpendo.00501.2020

Liver glycogen-induced enhancements in hypoglycemic ... hepatic glucose uptake (NHGU) was low (1.8±0.5 mg/kg/min) in NG because insulin was basal. 206. However, it was four-fold higher in HG and HG-HeadEu as a result ...

5. withpower.com withpower.com/trial/phase-1-hypoglycemia-7-2018-cbe4e

Sugar Doses for Low Blood Sugar · Info for Participants Research shows that increasing liver glycogen can enhance the body's response to low blood sugar by boosting hormone levels that help raise blood sugar. This ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534841/

Hypoglycemia - StatPearls - NCBI Bookshelf - NIH Glycogenolysis maintains serum glucose levels over 8 to 12 hours until glycogen stores are depleted.

7. nature.com nature.com/articles/s41598-024-80604-x

Association between low fasting glucose of the living donor ... A DFG level < 85 mg/dL is associated with higher risk of graft failure after LDLT, especially when combined with other risk factors.