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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.
Background:
Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve
insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body
burn energy.
Objective:
To learn more about how BAT works to burn energy.
Eligibility:
People ages 18-40 with a body mass index between 18 and 40
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Dietitian interview
Participants will have an overnight baseline visit. This includes:
Repeats of screening tests
Exercise test
Scans. For one scan, a radioactive substance is injected into the arm.
FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are
injected in one arm. Blood glucose and insulin levels are measured from the other.
Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate.
Monitors on the body measure heart rate, movement, and temperature.
Optional fat biopsy: A small piece of tissue is removed with a needle.
Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron.
Men will be randomly get either the drug or a placebo.
All participants will have a visit after 2 weeks of the pills. They will repeat the screening
tests.
Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests.
Participants will keep food and medication diaries.
Participants will have a follow-up visit 2 weeks after stopping the pills. This includes
heart tests.
Background:
The body uses energy from calories for basic functions like breathing and digesting food.
Over time, when a person eats more calories than they burn, they may become overweight or
obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue
to learn more about metabolism. That is how the body uses food and other nutrients for normal
function and energy. This research may help to develop new treatments for obesity and related
diseases.
Objective:
To learn more about the role of fat and muscle in metabolism, particularly how fat and muscle
store and use energy.
Eligibility:
Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected
by the surgeon.
Design:
Participants will be screened by their regular NIH doctor. Then researchers will contact them
about this study.
Participants will not have to make extra visits to NIH for this study.
Researchers will collect samples during the participant s surgery. These will be fat tissue
and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be
discarded. Collecting the tissue will not add any time or any extra incisions than what is
required for the surgery.
After surgery, blood will be drawn. Some participants will have this done in the pre-op or
post-op room. Others will have this done during their hospital stay.
Background:
- Changes in how a person s body burns energy or calories can affect their weight over time.
The lowest level of energy the body needs to function is called basal metabolic rate. In the
cold, we burn extra energy, even before we start to shiver. This is called non-shivering
thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers
want to learn more about this type of energy burning and how it is regulated. They hope this
will help treat obesity in the future.
Objectives:
- Sub-study 1: to better understand how non-shivering thermogenesis works.
- Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate.
- Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic
receptor agonist, on brown fat activity.
Eligibility:
- Healthy, lean adult males ages 18 to 35.
Design:
- Participants will be screened with medical history, physical exam, blood test, and EKG.
- For sub-studies 1 and 2:
- Participants will receive one X-ray scan.
- Each day, all participants will:
<TAB>- Have height and weight measured, and have urine collected.
- Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and
computer. They will wear small non-invasive devices to monitor activity, heart rate,
temperature, and shivering.
<TAB>- Walk for 30 minutes.
-For sub-study 3:
- Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs
- Each stay, all participants will:
<TAB>- Have height and weight measured, and have urine collected.
- Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and
computer. They will wear small non-invasive devices to monitor activity, heart rate,
temperature, and shivering.
- Participants will be compensated for their time and participation at the end of the
study
