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NCT04118374 · ClinicalTrials.gov registry record · NA
A Study to Determine Iatrogenic Hyperinsulinemia's Contribution to Insulin Resistance and Endothelial Dysfunction in Type 1 Diabetes
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT04118374: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT04118374 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04118374, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
The investigators will test the hypothesis that reducing insulin doses using a low carbohydrate diet (LCD) will be associated with with improved insulin sensitivity (Aim 1) and blood vessel health (Aim 2).
Primary Outcome
Participants completed both a one-week RCD and a one-week SCD, separated by a three-week washout. After each intervention, we measured insulin sensitivity using a hyperinsulinemic-euglycemic clamp.To express GIR in mg of glucose per kg of fat-free mass per minute (mg/kg FFM/min), we divided the dextrose infusion rate by the fat-free mass determined by DEXA. Insulin sensitivity showed no significant difference between diets. GIR was 8.1 mg/kg FFM/min after the RCD and 8.6 mg/kg FFM/min after the
Interventions
- OTHER Standard Carb Diet
- OTHER Low Carb Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-11-24 |
| Est. Completion | 2024-06-21 |
| Phase | NA |
What the finished NCT04118374 record still lists
NCT04118374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Carb Diet is the first listed.
NCT04118374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04118374 about?
NCT04118374 is a clinical study titled "A Study to Determine Iatrogenic Hyperinsulinemia's Contribution to Insulin Resistance and Endothelial Dysfunction in Type 1 Diabetes". The investigators will test the hypothesis that reducing insulin doses using a low carbohydrate diet (LCD) will be associated with with improved insulin sensitivity (Aim 1) and blood vessel health (Aim 2).
What is the current status of trial NCT04118374?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2021-11-24. Estimated completion is 2024-06-21.
What interventions are being tested in trial NCT04118374?
The interventions under investigation include: Standard Carb Diet (OTHER), Low Carb Diet (OTHER).
Who is sponsoring clinical trial NCT04118374?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04118374's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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