Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants
are not being recruited or enrolled.
Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate.
The study is not open to everyone who meets the eligibility criteria.
Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to
gain access to the drug, biologic, or medical device being studied.
Studies Seeking Patients
Metabolism refers to the many chemical pathways by which various compounds, including food,
are processed and used in the body. People with non-alcoholic fatty liver disease (NAFLD)
have too much fat in their liver cells, but what causes it is unclear. One explanation is
that people with NAFLD process food and metabolize it differently than people without NAFLD.
Researchers want to compare how food is metabolized in people with and without NAFLD.
To better understand how food intake influences the development and progression of NAFLD.
People ages 18 and older with NAFLD or with a non-NAFLD metabolic syndrome
Healthy volunteers ages 18 and older
Participants will be screened with medical history, surveys, physical exam, and blood tests.
This will have ultrasound of the abdomen. This uses sound waves to image internal organs.
Participants will stay at the Clinical Center for 2 nights.
They will fast he first night.
On the second day they will:
Have their metabolism monitored in a metabolism research room for 24 hours
Have a catheter inserted into an arm vein for several blood tests
Drink an Ensure Plus for breakfast
Have solid meals for lunch and dinner
Have several urine tests.
The final morning, they will:
Have more blood tests.
Have a DXA test to measure the fat in the body. They will lie on their backs for 15-25
minutes while an x-ray machine is positioned over areas of the body.
The trial is Open with a status of Recruiting.
Yaron Rotman, M.D.
Catherine A Nadal, R.N.
- Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver
cells. It is associated with obesity, high blood pressure, high cholesterol, and
diabetes. Some people with NAFLD only have excess fat in the liver. However, other
people may develop a worse form of NAFLD with liver injury and scarring. This form,
called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer,
and death. Not much is known about why some people develop NASH and others do not.
- Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage
in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of
vitamin E used in these studies is almost 40 times the recommended amount of vitamin E
intake from food. It is unclear whether a lower dose could achieve the same effect.
Researchers also want to study how vitamin E works at different doses to treat NAFLD.
- To find out the most effective dose of vitamin E to treat NAFLD.
- To gain a better understanding of how NAFLD and NASH develop, and predict who will
respond to treatment.
- Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease.
- Participants will be screened with a physical exam and medical history. Blood and urine
samples will be collected.
- For the first 12 weeks of the study, participants will meet with a nutritionist. They
will have personalized diet and exercise plans. Treatment will be monitored with diaries
and questionnaires to fill out at home. Participants will also wear a pedometer to
measure physical activity.
- After the 12-week period, participants will have a full physical examination with the
- Blood tests
- Glucose tolerance tests
- Imaging studies (DEXA scan and magnetic resonance imaging)
- Liver and fatty tissue biopsy
- Two weeks after the tests, participants will start vitamin E treatment. They will take
up to two pills a day, taken with fat-containing foods.
- 4 weeks after starting treatment they will have a repeat full evaluation with imaging
tests, blood work, and liver and fat biopsies.
- Participants who are taking vitamin E will take it for up to 120 weeks. They will have
monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another
full evaluation, with imaging tests, blood work, and liver and fat biopsies.
The trial is Open with a status of Active, not recruiting.
Yaron Rotman, M.D.