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NCT01816165 · ClinicalTrials.gov registry record · Phase 3
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes
A Phase 3 study of Type 1 Diabetes, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT01816165: Completed Phase 3 study of Type 1 Diabetes, sponsored by University of Colorado, Denver.
NCT01816165 is a Phase 3 study of Type 1 Diabetes that has completed, run by University of Colorado, Denver. The registered enrollment target is 28 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816165, a Phase 3 study of Type 1 Diabetes, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated fatty acid lowering with acipimox will improve insulin action and blood vessel function and have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D treatment that may significantly improve current management of TID and of cardiovascular disease (CVD) risk in this high risk population.
Primary Outcome
Evaluate the impact of Non esterified fatty acid (NEFA)-lowering on insulin sensitivity in T1D versus non-DM. Glucose infusion rate is reported normalized to lean body weight in kg and to final insulin concentration. The unit of measure reflects the rate at which glucose needs to be infused to maintain a normal blood sugar in the setting of a given serum insulin level from an insulin infusion. As such, a higher number means more glucose was needed and indicates greater sensitivity to insulin.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acipimox
Study Locations (1)
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-06-24 |
| Phase | Phase 3 |
What the finished NCT01816165 record still lists
NCT01816165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01816165 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01816165 about?
NCT01816165 is a clinical study titled "Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes". Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated fatty acid lowering w...
What is the current status of trial NCT01816165?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2011-06. Estimated completion is 2015-06-24.
What conditions does trial NCT01816165 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT01816165?
The interventions under investigation include: Placebo (DRUG), Acipimox (DRUG).
Who is sponsoring clinical trial NCT01816165?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01816165 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01816165's enrollment target sits among peer trials
28 132nd of 198 higher than 65 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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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