Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes (AcT1)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: Placebo; Drug: Acipimox

Study type: Interventional

Funder types: Other

Identifiers

NCT01816165

11-0649

6181 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 25 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women, with and without type 1 diabetes between 25-59 years of age,

2. HbA1c 6.0-9.5 (T1D only),

3. Subjects who are willing to commit to:

   • 14 days of prescribed diet,
   • two 44 hour inpatient stays, and
   • two muscle biopsies.

Exclusion criteria

1. Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia,
2. Tobacco use,
3. Pregnancy,
4. Steroid use,
5. Scheduled physical activity >3 days a week,
6. Angina or any other cardiovascular or pulmonary disease,
7. History of chronic obstructive pulmonary disease or asthma,
8. Systolic blood pressure >190 at rest or >250 with exercise, or
9. Diastolic pressure >95 at rest, or >105 with exercise,
10. Proteinuria (urine protein >200 mg/dl), or
11. Creatinine > 2 mg/dl, suggestive of severe renal disease,
12. Severe Proliferative retinopathy,
13. Niacin treatment,
14. History of peptic ulcers,
15. History of hereditary angioedema, and
16. C1 esterase deficiency.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

Acipimox

Experimental group

Description:

Drug: acipimox

Treatment:

Drug: Acipimox

Placebo

Placebo Comparator group

Description:

Drug: Placebo

Treatment:

Drug: Placebo