Phase 3
Completed N=18
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes
Source: ClinicalTrials.gov NCT01816165 ↗Enrolled (actual)
18
Serious AEs
2.9%
Results posted
Jan 2022
Primary outcomePrimary: Insulin Sensitivity: M-value From Hyperinsulinemic Euglycemia Clamp Study — 4.65; 3.67; 8.8; 9.05 mg/kg*minute*microIU/mL*100
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity: M-value From Hyperinsulinemic Euglycemia Clamp Study |
4.65; 3.67; 8.8; 9.05 | — |
| PRIMARY 24 Hour Mean Fatty Acid Levels |
343; 297; 298; 335 | — |
| PRIMARY Percent Flow-mediated Brachial Artery Dilation |
8.21; 8.82; 5.88; 7.32 | — |
| PRIMARY State 3 Mitochondrial Oxygen Consumption |
26.1; 24.9; 30.2; 29.7; 38.0; 36.9 | — |
| SECONDARY Oxidative Stress and Inflammatory Markers: Interleukin 6 (IL6) |
2.8; 4.2; 2.6; 3.5 | — |
| SECONDARY Oxidative Stress and Inflammatory Markers: TNFalpha |
1.76; 1.71; 1.56; .91 | — |
| SECONDARY Oxidative Stress and Inflammatory Markers: High-sensitivity C-reactive Protein (hsCRP) |
3.19; 1.98; 1.43; 1.44 | — |
| SECONDARY Oxidative Stress and Inflammatory Markers: Adiponectin |
11.6; 14.9; 7.3; 5.8 | — |
| SECONDARY Oxidative Stress and Inflammatory Markers: Plasminogen Activator Inhibitor (PAI-1) |
— | — |
| SECONDARY Heart Rate Variability |
1.37; 1.43; 1.59; 1.69 | — |
| SECONDARY Arterial Stiffness (PWV) |
9.24; 9.91; 6.97; 7.4 | — |
| SECONDARY Arterial Stiffness (AI) |
21.4; 19.7; 11.1; 12.4 | — |
| SECONDARY Metabolic Markers: Continuous Glucose Monitoring Measures |
8.82; 9.09; 3.64; 3.64 | — |
| SECONDARY Metabolic Markers: Mean 24 Hour Triglyceride and Glucose Levels |
135; 131; 87; 89; 59; 68 | — |
| SECONDARY Metabolic Markers: Insulin |
48; 47; 20; 21 | — |
| SECONDARY Metabolic Markers: Glycerol |
86; 75; 63; 69 | — |
| SECONDARY Vascular Markers |
4.92; 4.9; 4.83; 4.12 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women, with and without type 1 diabetes between 25-59 years of age,
- HbA1c 6.0-9.5 (T1D only),
- Subjects who are willing to commit to:
- 14 days of prescribed diet,
- two 44 hour inpatient stays, and
- two muscle biopsies.
Exclusion Criteria
- Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia,
- Tobacco use,
- Pregnancy,
- Steroid use,
- Scheduled physical activity >3 days a week,
- Angina or any other cardiovascular or pulmonary disease,
- History of chronic obstructive pulmonary disease or asthma,
- Systolic blood pressure >190 at rest or >250 with exercise, or
- Diastolic pressure >95 at rest, or >105 with exercise,
- Proteinuria (urine protein >200 mg/dl), or
- Creatinine > 2 mg/dl, suggestive of severe renal disease,
- Severe Proliferative retinopathy,
- Niacin treatment,
- History of peptic ulcers,
- History of hereditary angioedema, and
- C1 esterase deficiency.
Data sourced from ClinicalTrials.gov (NCT01816165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.