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Protocol Details

Dynamic Post-Prandial Metabolism in Patients with Non-Alcoholic Fatty Liver Disease

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-DK-0174

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Metabolomics;
Non-Alcoholic Steatohepatitis;
Non-Alcoholic Fatty Liver Disease;
Energy Expenditure

Recruitment Keyword(s)

None

Condition(s)

Liver Disease;
Fatty Liver

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

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.

Objective:

To better understand how food intake influences the development and progression of NAFLD.

Eligibility:

People ages 18 and older with NAFLD or with a non-NAFLD metabolic syndrome

Healthy volunteers ages 18 and older

Design:

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.

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Eligibility

INCLUSION CRITERIA:

For the entire cohort:

-Male or female aged > 18 years

-Ability to provide informed consent

For group 1 subjects (NAFLD)

-Biopsy-proven NAFLD within 2 years prior to screening, OR

-The presence of at least two of the following criteria:

-Suggestion of liver fat by an imaging study (ultrasound, CT scan, MRI or MR spectroscopy) performed in the 6 months prior to screening

-Elevated aminotransferase levels (ALT > 31 U/L for men or > 19 U/L for women, or AST > 30 U/L) on at least two occasions in the 6 months preceding enrollment.

-Presence of the metabolic syndrome, defined according to the modified AHA/NCEP criteria as the presence of at least three of:

i. Abdominal obesity, defined as waist circumference > 102 cm for men or > 88 cm for women

ii. Elevated triglycerides (> 150 mg/dL) or the use of medication to lower triglycerides

iii. Reduced HDL cholesterol (< 40 mg/DL for men or < 50 mg/dL for women)

iv. Elevated blood pressure (> 135/80 mmHg) or use of medication for hypertension

v. Elevated fasting glucose levels (> 100 mg/dL) or use of anti-diabetic medication

For the purpose of inclusion, the presence of overt diabetes mellitus type 2 will be considered equivalent to the presence of the metabolic syndrome, even if the other criteria are absent.

For group 2 subjects (non-NAFLD metabolic syndrome):

-Evidence of metabolic syndrome

-Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to 19 U/L for women, or AST less than or equal to 30 U/L) at screening

-Absence of liver fat by imaging or liver biopsy within 6 months of screening

For group 3 subjects (healthy volunteers):

-No history of known liver disease

-Not on any regular systemic medications (with the exception of oral contraceptives)

-BMI <= 25 kg/m2

-Non diabetic

-Normal transaminases and fasting glucose (<95 mg/dL)

EXCLUSION CRITERIA:

1. Concomitant liver disease such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency

2. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment > 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.

3. Estimated average alcohol consumption > 30 g/d for men or > 20 g/d for women in the 6 months prior to enrollment, or binge-drinking behavior .

4. Gain or loss of > 10% body weight within the 6 months prior to enrollment.

5. Decompensated liver cirrhosis, defined as a past or present occurrence of a decompensation event (variceal bleeding, ascites, spontaneous bacterial peritonitis, encephalopathy or hepatocellular carcinoma or by albumin < 3 g/dl, PT > 3 seconds above the upper limit of the norm, platelet count < 70,000 or total bilirubin > 2 mg/dL (in the absence of Gilbert s syndrome).

6. Pregnancy or lactation

7. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen

8. Disorders interfering with substrate absorption such as gastric bypass surgery, malabsorption disorders, use of orlistat or bile acid sequestrants, or extensive small bowel resection.

9. Diabetic patients requiring insulin treatment

10. Lactose intolerance or allergy to Ensure or one or more of its components

11. Hyper/hypothyroidism

12. Inability to remain sedentary for 4 hours, or to remain for 26-30 hours in the metabolic chamber

13. Inability to obtain vascular access for the required blood samples


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Yaron Rotman, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Yaron Rotman, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 10N248C
10 CENTER DR
BETHESDA MD 20814
(301) 451-6553
rotmanyaron@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02520609

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