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

NCT ID: NCT01816165

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-06-24

Brief 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acipimox

Drug: acipimox

Group Type: EXPERIMENTAL

Acipimox

Intervention Type: DRUG

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.

Placebo

Drug: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Acipimox

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Olbetam

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Schauer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

6181

Identifier Type: OTHER

Identifier Source: secondary_id

11-0649

Identifier Type: -

Identifier Source: org_study_id