Insulin Infusion for Non-alcoholic Fatty Liver Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who have used certain medications within 90 days before screening, like antidiabetic drugs other than metformin and some lipid-lowering drugs. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug for Non-alcoholic Fatty Liver Disease?
Research suggests that insulin-sensitizing agents, which help the body use insulin more effectively, may improve liver health in people with Non-Alcoholic Fatty Liver Disease (NAFLD). These agents have been shown to reduce insulin resistance, which is a key factor in the development of NAFLD, and improve liver function in some studies.12345
Is insulin infusion safe for humans?
How does insulin infusion differ from other treatments for non-alcoholic fatty liver disease?
Insulin infusion for non-alcoholic fatty liver disease is unique because it directly uses insulin, a hormone that helps regulate blood sugar, which may influence liver fat content. Unlike other treatments that focus on insulin sensitizers, this approach involves administering insulin itself, potentially offering a different mechanism to address the condition.1341112
What is the purpose of this trial?
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.
Research Team
Joshua R. Cook, MD, PhD
Principal Investigator
Columbia University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pancreatic Clamp Procedure
Participants undergo two pancreatic clamp procedures to assess the impact of insulin infusion rate on blood glucose levels.
Follow-up
Participants are monitored for safety and effectiveness after the pancreatic clamp procedures.
Treatment Details
Interventions
- 20% D-glucose (aq)
- [6,6-2H2] D-glucose
- Glucagon
- Growth Hormone, Human
- Insulin human
- Octreotide Acetate
Insulin human is already approved in European Union, United States, Canada, Japan, China for the following indications:
- Diabetes mellitus type 1
- Diabetes mellitus type 2
- Diabetes mellitus type 1
- Diabetes mellitus type 2
- Diabetes mellitus type 1
- Diabetes mellitus type 2
- Diabetes mellitus type 1
- Diabetes mellitus type 2
- Diabetes mellitus type 1
- Diabetes mellitus type 2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Albert Einstein College of Medicine
Collaborator