Sucrose for Liver Metabolism

Phase-Based Estimates
1
Effectiveness
1
Safety
School of Health Professions at UTSW, Dallas, TX
Sucrose - Other
Eligibility
18 - 65
All Sexes
Eligible conditions
Liver Metabolism

Study Summary

Alcohol Induced de Novo Lipogenesis in Women

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Sucrose will improve 1 primary outcome in patients with Liver Metabolism. Measurement will happen over the course of 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption.

Hour 7
Mean Change in Hepatic De Novo Lipogenesis (DNL)

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
A. ETOH

This trial requires 20 total participants across 3 different treatment groups

This trial involves 3 different treatments. Sucrose is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

A. ETOH
Other
5 Males and 5 Females will receive deuterated water and drink 2.15 ounces of alcohol in the form of vodka and have de novo Lipogenesis measured at 11 time points during and after.
C. Sucrose
Other
5 Females will receive deuterated water and drink a solution containing water and 35 grams of sucrose, and have de novo Lipogenesis measured at 11 time points during and after.
ETOH + Sucrose5 Females will receive deuterated water and drink 1.72 ounces of alcohol in the form of vodka + 7 grams of sucrose and have de novo Lipogenesis measured at 11 time points during and after.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption for reporting.

Who is running the study

Principal Investigator
J. F.
Prof. Justin Fletcher, Assistant Professor
University of Texas Southwestern Medical Center

Closest Location

School of Health Professions at UTSW - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received newly diagnosed for Liver Metabolism. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or Female
Ages 21 - 45
Healthy
is considered normal A BMI between 18.5 and 29.9 is classified as normal weight. show original
Normal Nutritional Status
Ability to speak and understand English
Light to moderate alcohol consumption (≤1 drink a day (~14g) in women and ≤2 drinks a day (~28 g) in men)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can liver metabolism be cured?

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Liver metabolism is fundamentally the same in both groups of patients. It cannot be cured. The main difference is that patients with a chronic hepatitis process, whose liver functions begin to decline early in the course of their illness, will have a poorer prognosis because their initial hepatic metabolic function is not as good as that of patients whose liver function is the same or who have normal liver function.

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What causes liver metabolism?

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Drugs or their active metabolites can be a source of metabolite burden by disrupting hepatic functioning at the level of cellular metabolism. Identifying these processes can improve patient management.

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What is liver metabolism?

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The liver is a vital organ located in the upper portion of the thoracic cavity, located between the diaphragm and the stomach. Livers main functions relate to detoxification, elimination, production of lipids (including cholesterol), production of vitamin K and other vitamin K-related functions. Liver enzymes are enzymes secreted by the liver parenchyma. Liver damage may occur due to excessive alcohol consumption, drugs, heavy metals and viral infections.

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What are the signs of liver metabolism?

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Liver metabolite abnormalities are common in liver cirrhosis. Such abnormalities may include blood ammonia, branched-chain amino acids, beta-hydroxybutyroic acid, and alanine. The signs of liver cell necrosis are jaundice, liver dysfunction with erythrocyte abnormalities, and increased alkaline phosphatase activity. Other signs of liver injury may include an increase in lactate dehydrogenase and gamma-glutamyl transpeptidase. Increased hepatic venous blood ammonia concentrations may be an indicator of hepatorenal syndrome. Findings from a recent study depend on the stage of liver disorder in question.

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What are common treatments for liver metabolism?

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In the last decade, the treatment of liver metabolism has improved significantly. A number of drugs and dietary supplements are now routinely used. Furthermore, the treatment algorithms for the treatment of liver metabolism are more standardized and are evolving. Future challenges for the treatment of liver metabolism will include the development of more reliable biomarkers and a better understanding of the pathophysiology and the treatment of diseases related to liver metabolism.

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How many people get liver metabolism a year in the United States?

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About 2.2 million people are treated per year in the United States with prescription drug for liver metabolism. A growing number of patients require long-term drug therapy, at least a few years.

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Is sucrose typically used in combination with any other treatments?

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The use of sucrose in combination with other treatments, especially when used routinely to maintain normoglycemia during intravenous nutrition, may be associated with the development of hyperglycemia and hyperosmolality. Further exploration of whether sucrose needs to be used in combination with other treatments for patients receiving intravenous nutrition is warranted.

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Does liver metabolism run in families?

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Families with diabetes show changes in hepatic metabolism and alterations in the hepatic enzymes. Results from a recent clinical trial indicate that these changes would be unlikely if the abnormalities found in family type 2 diabetic patients were only attributable to genetic factors. Thus, besides the well known hyperglycaemia, some other alterations must be involved to obtain the phenotype observed between type 1 and type 2 diabetes.

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Have there been other clinical trials involving sucrose?

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A placebo-controlled clinical trial evaluating sucrose in patients suffering from ICP would be difficult since these patients do not exhibit the symptoms that would allow this test to be clinically useful.

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Has sucrose proven to be more effective than a placebo?

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The study suggests that sucrose administered twice daily at 40% of the daily habitual oral sucrose intake was better than an matched placebo in the improvement of liver function and the reduction of bilirubin levels in obese patients with NASH and C-IIIRD at baseline. Moreover, the results suggested that sucrose is effective in reducing the rate of hepatic dysfunction in patients with NASH and C-IIIRD. Data from a recent study need to be established in randomized trials.

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What does sucrose usually treat?

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[Somewhere between three-quarters and half of people with nonvariceal alcoholic pancreatitis are being inappropriately dosed with sucrose for the treatment of alcoholic symptoms such as abdominal pain, indigestion or weight loss. When this medication is used inappropriately, over 40% will have serious complications. (source: http://www.nhs-uk.org/healthcare/dialogues/alcoholics-overdose-treatment/.)

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