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Insulin Infusion for Non-alcoholic Fatty Liver Disease
Study Summary
This trial will study how changing the rate of insulin infusion affects blood glucose levels in people with NAFLD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your blood insulin level is too high when you haven't eaten for a while.I am between 18 and 65 years old and use effective birth control if I can have children.I can provide informed consent in English or Spanish.I understand English or Spanish.I have been diagnosed with or am at high risk for NAFLD/MAFLD by a specialist.I have given my written consent in English or Spanish for all study procedures.You have signs of insulin resistance based on specific criteria.Your body mass index is between 25 and 39.9.
- Group 1: Maintenance hyperinsulinemia (MH) protocol
- Group 2: Reduction toward euinsulinemia (RE) protocol
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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