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Impact of exocrine insufficiency of pancreas and supplementation of pancreatic digestive enzymes on nonalcoholic fatty liver disease (REMOTE study)

Impact of exocrine insufficiency of pancreas and supplementation of pancreatic digestive enzymes on nonalcoholic fatty liver disease (REMOTE study) - Classification and treatment of NAFLD based on pancreatic exocrine function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026825
Enrollment
60
Registered
2017-06-01
Start date
2017-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Before starting enrollment

Interventions

Evaluation and encouraging in terms of energy-balanced life style and oral administration of pancrelipase (600 mg a day for 24 weeks) Evaluation and encouraging in terms of energy-balanced life style

Sponsors

Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Ultrasound reveals fatty liver as two or more following criteria are fulfilled. i. Liver/kidney contrast ii. Vascular blurring in the liver iii. Deep-attenuation of echo-beam in the liver 2) Shear wave elastography is 1.41 m/sec or faster. 3) A written informed consent is obtained from a patient him/her self.

Exclusion criteria

Exclusion criteria: 1) HBV positive 2) HCV positive including a SVR12 case 3) Alcohol consumption more than 20g/day 4) An organic diseases of pancreas or a past History of chronic pancreatitis 5) Allergy against porcine proteins 6) Already taking pancrelipase 7) Taking a medication for diabetes mellitus or HbA1c is 8 or higher 8) Serum triglyceride concentration is 1000 mg/dl or higher 9) Other serious conditions judged to be inadequate by a responsible doctor

Design outcomes

Primary

MeasureTime frame
Ultrasound findings for fatty liver 24 weeks after the enrollment

Secondary

MeasureTime frame
Shear wave velocity of the liver evoked by acoustic radiation force impulse

Countries

Japan

Contacts

Public ContactTakeshi Suda

Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital Department of Gastroenterology and Hepatology

tspitt@med.niigata-u.ac.jp81-25-777-3200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026