AcT1Role of Lipotoxicity in Insulin Resistance, Vascular, and Mitochondrial Dysfunction in Type 1 Diabetes
Acipimox
+ Placebo
Autoimmune Diseases+7
+ Endocrine System Diseases
+ Hyperinsulinism
Treatment Study
Summary
Study start date: June 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 25 to 59 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location