Healthy Clinical Trial
Official title:
Role of Mitochondrial Dysfunction in Non-Alcoholic Fatty Liver Disease
Verified date | November 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity
and ~8 million of these individuals have a progressive form of the disease, non-alcoholic
steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which
individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a
prelude to the development of end-stage liver disease.
The study of NAFLD has been limited by several factors, including the difficulties associated
with studying liver metabolism in vivo in humans. Our group has pioneered new methods that
use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism in humans
with a goal of directly studying the pathophysiology of bland steatosis and NASH. In this
study, these noninvasive methods will be used to characterize and compare the metabolic
alterations that accompany bland steatosis and NASH and test the hypothesis that detects if
hepatic mitochondrial metabolism contribute to both disorders. Such characterization is
fundamental to establishing a rational approach to the prevention and treatment of NAFLD and
may provide simple, non-invasive methods to differentiate benign and progressive forms of
NAFLD.
This proposal will be addressed via separate isotopic studies occurring at different time
points during a prolonged fast. In subjects with NAFLD, these studies will be carried out
before and after treatment with Vitamin E or placebo.
Healthy subjects will participate in initial baseline studies only without Vitamin E or
placebo intervention.
The study is designed to harness the physiologic changes that occur with short- and long-term
fasting to provide a rapid and cost-effective method to accomplish the aims of the
application.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: NAFLD/NASH SUBJECTS - Male and Female, Age 18-65 years of all racial and ethnic origins - Hepatic steatosis by radiologic study with or without liver enzyme elevation - BMI < 35 kg/m2 - English or Spanish language - Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol - May also have Type 2 Diabetes (T2DM) with: Hemoglobin A1C < 8.5 % of total Prior, current or no oral antidiabetic medication usage CONTROL SUBJECTS: - Age 18-65 years. - BMI = 35 kg/m2 - English or Spanish language - Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol - May also have T2DM with: Hemoglobin A1C < 8.5 % of total Prior, current or no oral antidiabetic medication usage Exclusion Criteria: ALL SUBJECTS: - Diabetes type 1 - Diabetes type 2 with: Hemoglobin A1C < 8.5 % of total Current or prior insulin usage - Medications or conditions that confound the diagnosis of NAFLD - Excessive alcohol intake (>30 g/day in men and >20 g/day in women) - Chronic liver disease other than NAFLD/NASH - Glucocorticoids - Medications or conditions that alter hepatic metabolism - Autoimmune disorders - Current or chronic infection - Other endocrine disorders - Recent weight loss (> 10 lbs. within the past 3 months) - Prescription weight-loss medications - Medical conditions likely to increase the risk of intervention Renal insufficiency (creatinine > 1.4 mg/dL) Baseline metabolic acidosis Congestive heart failure - Conditions or behaviors likely to affect the conduct of the study Pregnancy and breastfeeding confirmed by urine pregnancy test prior to all imaging or invasive procedure such as the euglycemic clamp, stable isotope studies, as well as prior to initiation of Vitamin E. - Concurrent participation in another research project - Inability to accept treatment assignment - Major psychiatric disorder or substance abuse CONTROL SUBJECTS (in addition to the above): - Liver disease Elevated liver function tests Hepatic steatosis - Metabolic syndrome Hypertriglyceridemia (fasting plasma triglycerides > 150 mg/dL). Systolic blood pressure > 140 mmHg Diastolic blood pressure > 80 mmHg - Exercise above activities of daily living |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Jeffrey Browning | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Measurement of percentage of Liver Fat by MRI | Measurement of percentage of Liver Fat by MRI at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks. | baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | |
Primary | Change in Measurement of Insulin Sensitivity via Hyperinsulinemic glucose clamp | Measurement of insulin sensitivity by glucose disposal rate (mg/Kg/min) via hyperinsulinemic glucose clamp @ baseline and 16 weeks. | 4 months | |
Primary | Change in Measurement of glucose metabolism turnover by non-radioactive isotopic infusion and recovery | Measurement of glucose metabolism turnover (ug/Kg/min) in the liver by non-radioactive isotopic infusion and recovery @ baseline and 16 weeks. | 4 months |
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