Study Summary
This trial will study how changing the rate of insulin infusion affects blood glucose levels in people with NAFLD.
- Obesity
- Insulin Resistance
- Prediabetes
- Hyperinsulinemia
- Non-alcoholic Fatty Liver Disease (NAFLD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 9 Secondary · Reporting Duration: 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
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Maintenance hyperinsulinemia (MH) protocol
1 of 2
Reduction toward euinsulinemia (RE) protocol
1 of 2
Active Control
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: Reduction toward euinsulinemia (RE) protocol · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor