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Hormone Therapy

Insulin Infusion for Non-alcoholic Fatty Liver Disease

Phase 1

Recruiting

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

Diagnosed with or clinically judged to be at high risk for non-alcoholic fatty liver disease (NAFLD), also known as metabolic-associated fatty liver disease (MAFLD), by hepatologist or other qualified specialist physician and the condition is listed as an active problem in the electronic medical record

Be older than 18 years old

Must not have

Unable to provide informed consent in English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured every 5 minutes x 4 at the end of each steady-state iir period, up to 425 minutes from the start of the procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how changing the rate of insulin infusion affects blood glucose levels in people with NAFLD.

Who is the study for?

This trial is for adults aged 18-65 with a BMI of 25.0-39.9, who speak English or Spanish, have high fasting insulin levels and are at risk for non-alcoholic fatty liver disease (NAFLD). They must not be pregnant, breastfeeding, or have diabetes, severe infections recently, certain heart conditions or allergies to study materials.

What is being tested?

The study tests how different rates of insulin infusion affect blood glucose during a pancreatic clamp procedure in overweight individuals with NAFLD and insulin resistance. Participants will undergo two procedures comparing maintenance versus reduction of insulin infusion.

What are the potential side effects?

Potential side effects may include reactions at the infusion site due to IV administration and possible allergic reactions to the components used in the medicinal products or equipment.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with or am at high risk for NAFLD/MAFLD by a specialist.

Exclusion Criteria

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

Select...

I can provide informed consent in English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured every 5 minutes x 4 at the end of each steady-state iir period, up to 425 minutes from the start of the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured every 5 minutes x 4 at the end of each steady-state iir period, up to 425 minutes from the start of the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every 5 minutes x 4 at the end of each steady-state iir period, up to 425 minutes from the start of the procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Plasma glucose (absolute values) (units: mg/dL)

Plasma glucose (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)

Serum C-peptide (absolute values) (units: ng/mL)

+3 more

Secondary study objectives

Plasma glucose kinetics: endogenous glucose production (units: mg/kg/min)

Plasma glucose kinetics: rate of appearance (units: mg/kg/min)

Plasma glucose kinetics: rate of disappearance (units: mg/kg/min)

+6 more

Other study objectives

Serum or plasma glucagon (relative/change) (units: fold difference and/or ∆ng/L relative to previous time points)

Serum or plasma growth hormone (absolute values) (units: ng/mL)

Serum or plasma growth hormone (relative/change) (units: fold difference and/or ∆ng/mL relative to previous time points)

+1 more

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

Active Control

Group I: Reduction toward euinsulinemia (RE) protocolExperimental Treatment10 Interventions

The basal insulin infusion rate (IIR) necessary to maintain participants' mean basal fasting plasma glucose (mbFPG) will be determined during the basal titration period. Then, during the intervention period, the basal IIR will be reduced by up to 50%. Thus, the basal hyperinsulinemia expected due to underlying insulin resistance will be reduced toward euinsulinemia.

Group II: Maintenance hyperinsulinemia (MH) protocolActive Control10 Interventions

The basal insulin infusion rate (IIR) necessary to maintain participants' mean basal fasting plasma glucose (mbFPG) will be determined during the basal titration period. Then, during the intervention period, the IIR will remain at 100% of basal for the full duration (225 min). The IIR and resulting insulin levels are expected to be relatively high (cf. hyperinsulinemia) because of underlying insulin resistance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin human

2014

Completed Phase 2

~20

Octreotide Acetate

2016

Completed Phase 2

~260