Status:
COMPLETED
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes
Lead Sponsor:
University of Colorado, Denver
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
25-59 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01816165
Start Date
June 1 2011
End Date
June 24 2015
Last Update
January 21 2022
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045