CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
Acipimox +1 moredrug
Likely dose
Acipimox 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01816165
NCT01816165Phase 3Completed

Role of Lipotoxicity in Insulin Resistance, Vascular, and Mitochondrial Dysfunction in Type 1 Diabetes

University of Colorado, Denver·interventional·Posted Mar 22, 2013·Updated Jan 21, 2022

In Brief

A Phase 3 clinical trial evaluating Acipimox and Placebo for Type 1 Diabetes. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2013
Enrollment StartJun 1, 2011
Primary CompletionJun 24, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.3 years ago

Interventions

Acipimoxdrug

Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.

Placebodrug

Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day