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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

Men and women (using highly effective contraception if of childbearing potential, aged 18-65 years)

Able to understand written and spoken English and/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

Study 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

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I am between 18 and 65 years old and use effective birth control if I can have children.

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I understand English or Spanish.

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

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I have given my written consent in English or Spanish for all study procedures.

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

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,199 Total Patients Enrolled

Albert Einstein College of MedicineOTHER

286 Previous Clinical Trials

11,856,939 Total Patients Enrolled

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,791 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program open to adults who meet the age requirement?

"The age range set forth within the study's inclusion criteria is 18 to 65, with no exceptions."

Answered by AI

Has the FDA sanctioned the Reduction toward euinsulinemia (RE) protocol?

"We anticipate that Reduction toward euinsulinemia (RE) protocol will possess a low safety score of 1 since this is only at the early stages of clinical trials. Little data exists to confirm either its efficacy or security."

Answered by AI

Do I qualify to participate in this experiment?

"Eligible applicants to this study must be diagnosed with prediabetes and fall within the range of 18 to 65 years old. The clinical trial is looking for a total of 20 participants."

Answered by AI

How many patients are currently being administered this clinical experiment?

"Confirmed. The research recorded on clinicaltrials.gov suggests that, starting from February 1st 2023, this medical trial is actively searching for patients to fill in the remaining twenty openings at a single site."

Answered by AI

Is this experiment currently welcoming participants?

"Affirmative. Per the information on clinicaltrials.gov, this medical study is still open to recruitment and was initially posted in February 1st 2023; following a subsequent update on 2/2/2023, it now aims to enlist 20 individuals from one single location."

Answered by AI

What objectives is this research endeavor seeking to accomplish?

"The primary measurement of this trial will occur over a period spanning up to 425 minutes, and is focused on serum insulin levels in µIU/mL. Secondary measurements include triglyceride concentrations in mg/dL, free fatty acid levels also in mg/dL, and the relative change between these values across time points."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pancreatic Clamp in NAFLD

Joshua Cook 2023. "Pancreatic Clamp in NAFLD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724134.

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