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Hormone Therapy

Insulin Management for Non-alcoholic Fatty Liver Disease

Phase 1

Waitlist Available

Led By Joshua R Cook, MD, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women, ages 18-65 years

Diagnosed with or at high risk for metabolic dysfunction-associated steatotic liver disease (MASLD)

Must not have

Unwillingness to use only bedpan or urinal during specific procedures

Positive pregnancy test in women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6.5 hours of pancreatic clamp protocol

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effects of lowering insulin levels on liver glucose production and fat synthesis in individuals with insulin resistance and fatty liver disease. Participants will undergo two procedures with different insulin levels to compare the

Who is the study for?

This trial is for people who are overweight or obese, have insulin resistance (evidenced by high fasting insulin levels, prediabetes/impaired fasting glucose, or a HOMA-IR score of at least 2.73), and either have non-alcoholic fatty liver disease (NAFLD) or are at high risk for it.

What is being tested?

The study tests how lowering insulin affects liver glucose production versus fat creation in the liver. Participants will undergo two procedures with different insulin levels while their liver metabolism is monitored using special tracers.

What are the potential side effects?

Potential side effects may include reactions to the infusion pump, hormonal treatments like growth hormone and glucagon, and discomfort from consuming specific dietary products used during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am diagnosed with or at high risk for a type of liver disease related to metabolic dysfunction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unwilling to use only a bedpan or urinal during certain procedures.

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I am not pregnant or at risk of becoming pregnant.

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My liver isn't working properly.

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I can provide informed consent in English or Spanish.

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I have lost 5% or more of my original weight in the last 3 months.

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I have not had a severe infection or ongoing fever.

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My drug test was positive, but only for prescribed medications.

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I have had weight-loss surgery in the past.

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I have had diabetes or diabetes during pregnancy.

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I might have a complete lack of insulin.

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I have been diagnosed with a specific type of high cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6.5 hours of pancreatic clamp protocol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6.5 hours of pancreatic clamp protocol

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6.5 hours of pancreatic clamp protocol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endogenous glucose production (EGP) (absolute value)

Endogenous glucose production (EGP) (relative value)

Hepatic de novo lipogenesis (DNL) (absolute value)

+3 more

Secondary study objectives

Glucose kinetics: rate of appearance (absolute value)

Glucose kinetics: rate of appearance (relative value)

Glucose kinetics: rate of disappearance (absolute value)

+3 more

Other study objectives

Plasma glucagon level

Serum C-peptide level

Serum growth hormone level

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Reduction toward euinsulinemia (RE) protocolExperimental Treatment11 Interventions

On Pancreatic Clamp Visit 1 (RE Protocol), the insulin infusion rate (IIR) will be set to produce serum insulin levels of approximately 50% that of the screening fasting serum insulin level for the full duration of the pancreatic clamp. On Pancreatic Clamp Visit 2 (MH Protocol), the IIR will be set to approximately replicate the full fasting serum insulin for the duration of the pancreatic clamp. In both cases, plasma glucose will be clamped to approximately 140 mg/dL +/- 10%.

Group II: Maintenance hyperinsulinemia (MH) Protocol then Reduction toward Euinsulinemia (RE) ProtocolExperimental Treatment11 Interventions

On Pancreatic Clamp Visit 1 (MH Protocol), the insulin infusion rate (IIR) will be set to approximately replicate participants' endogenous fasting serum insulin levels based on screening visit data for the duration of the pancreatic clamp. On Pancreatic Clamp Visit 2 (RE Protocol), the IIR will be set to reduce serum insulin levels to roughly 50% of the screening fasting serum insulin for the duration of the pancreatic clamp. In both cases, plasma glucose will be clamped to approximately 140 mg/dL +/- 10%.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Octreotide Acetate

2016

Completed Phase 2

~260

Glucagon

2016

Completed Phase 4

~590