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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

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 40%. 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
Glucagon
2016
Completed Phase 4
~590

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,060 Total Patients Enrolled
Albert Einstein College of MedicineOTHER
287 Previous Clinical Trials
11,856,794 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,448 Total Patients Enrolled

Media Library

Insulin human (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05724134 — Phase 1
Prediabetes Research Study Groups: Maintenance hyperinsulinemia (MH) protocol, Reduction toward euinsulinemia (RE) protocol
Prediabetes Clinical Trial 2023: Insulin human Highlights & Side Effects. Trial Name: NCT05724134 — Phase 1
Insulin human (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724134 — Phase 1
~0 spots leftby Aug 2024
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