Diabetes Mellitus Clinical Trial
Official title:
The Effect of a Probiotic on Hepatic Steatosis
The purpose of this study is to determine whether probiotics, bacteria that may improve liver health, can effectively treat a chronic condition in diabetics that increases fat in the liver.
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease
in the United States and is also common in diabetics; unfortunately, research on NAFLD has
been limited. Safe, inexpensive, and well-tolerated treatments for NAFLD are needed. Recent
studies indicate that probiotics help to improve fat breakdown in mice. This study will
evaluate the efficacy of probiotic therapy to reduce fat accumulation in the livers of
people with NAFLD and diabetes.
Participants in this study will be randomly assigned to receive either a
probiotic-containing mixture or placebo once daily for 6 months. Blood tests, and magnetic
resonance spectroscopy will be used to assess participants at study start and at study
completion.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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