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Glucose Monohydrate Ph. Eur.

This article examines clinical trials involving the use of Glucose Monohydrate Ph. Eur. in patients with kidney-related conditions. These studies aim to evaluate the effectiveness and safety of various treatments, including peritoneal dialysis solutions and statins, in managing end-stage kidney disease and insulin resistance in kidney transplant recipients and chronic kidney disease patients.

Table of Contents

What is Glucose Monohydrate?

Glucose monohydrate is a form of glucose (sugar) that contains one molecule of water. It’s also known as dextrose monohydrate. In medical settings, it’s often used as a source of energy and hydration for patients[1].

Medical Uses of Glucose Monohydrate

Glucose monohydrate is used in various medical treatments, primarily as a source of carbohydrates (energy) for patients. It’s often administered intravenously (through a vein) or used in solutions for specific medical procedures[1].

Glucose Monohydrate in Peritoneal Dialysis

One significant use of glucose monohydrate is in peritoneal dialysis solutions for patients with End-Stage Kidney Disease (ESRD). Peritoneal dialysis is a treatment that helps remove waste products from the blood when the kidneys can’t do this effectively[2].

In peritoneal dialysis solutions, glucose monohydrate serves several purposes:

  • It acts as an osmotic agent, helping to remove excess fluid from the body
  • It provides energy to the patient
  • It helps maintain the balance of electrolytes in the body

Different concentrations of glucose (1.36%, 2.27%, and 3.86%) are used in peritoneal dialysis solutions to meet varying patient needs[2].

Glucose Monohydrate and Insulin Resistance Study

A clinical trial is being conducted to study the effects of a statin medication (Pravastatin) on insulin sensitivity in kidney transplant recipients and patients with chronic kidney disease. While glucose monohydrate is not the main focus of this study, it’s used in the glucose clamp technique to measure insulin sensitivity[1].

Potential Benefits of Glucose Monohydrate in Treatment

The use of glucose monohydrate in medical treatments, particularly in peritoneal dialysis, offers several potential benefits:

  • Provides necessary energy to patients
  • Helps in fluid removal from the body
  • Assists in maintaining electrolyte balance
  • Can be used in varying concentrations to meet individual patient needs

Possible Side Effects and Considerations

While glucose monohydrate is generally safe when used as directed in medical settings, there are some considerations:

  • High glucose concentrations in peritoneal dialysis solutions may contribute to increased blood sugar levels over time
  • Long-term use of high glucose solutions may affect the peritoneal membrane
  • Patients with diabetes may need careful monitoring when using glucose-based dialysis solutions

It’s important to note that the use of glucose monohydrate in medical treatments is always under the supervision of healthcare professionals who carefully monitor its effects and adjust treatments as necessary[2].

Aspect Study 1 (Insulin Resistance) Study 2 (ELIXIR)
Main Objective Assess effect of Pravastatin on insulin sensitivity Demonstrate non-inferiority of XyloCore vs. standard glucose PD solutions
Primary Endpoint Insulin sensitivity (hyperinsulinemic euglycemic glucose clamp) Weekly Kt/V urea
Key Secondary Endpoints Insulin secretion, hormone levels, insulin signaling pathways, faecal microbiota composition Lipid profile, HbA1c, insulin, EPO requirements, fatigue assessment, peritoneal ultrafiltration
Patient Population Kidney transplant recipients and chronic kidney disease patients End-stage kidney disease patients on peritoneal dialysis
Treatment Duration Not specified 6 months
Use of Glucose Monohydrate Ph. Eur. Component of comparator treatment Component of standard peritoneal dialysis solutions

FAQ

  • What is Glucose Monohydrate Ph. Eur. and how is it used in these clinical trials? Glucose Monohydrate Ph. Eur. is a form of glucose used in medical solutions. In these trials, it is a component of peritoneal dialysis solutions used to treat patients with end-stage kidney disease.
  • What conditions are being studied in these clinical trials? The trials focus on end-stage kidney disease, insulin resistance in kidney transplant recipients, and chronic kidney disease.
  • What is the main objective of the ELIXIR study? The main objective of the ELIXIR study is to demonstrate the non-inferiority of XyloCore, a glucose-sparing experimental solution, compared to standard glucose-based peritoneal dialysis solutions in terms of weekly Kt/V urea.
  • How long do the treatment periods last in these trials? The treatment periods vary, with the ELIXIR study having a 6-month treatment period, while the insulin resistance study duration is not specified in the provided information.
  • What are some of the key measurements being taken in these trials? Key measurements include weekly Kt/V urea, changes in lipid profiles (LDL, HDL, total cholesterol, triglycerides), HbA1c, insulin levels, hemoglobin, EPO requirements, and patient-reported fatigue levels.

Ongoing Clinical Trials on Glucose Monohydrate Ph. Eur.

  • Study on XyloCore and Drug Combination for Patients with End-Stage Kidney Disease Undergoing Peritoneal Dialysis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Germany Italy Spain Sweden

  • Study on Pravastatin’s Effect on Insulin Resistance in Kidney Transplant and Chronic Kidney Disease Patients

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Glucose Monohydrate Ph. Eur.: A form of glucose used in medical solutions, particularly in peritoneal dialysis fluids for kidney disease patients.
  • End-Stage Kidney Disease (ESRD): The final stage of chronic kidney disease where the kidneys can no longer function adequately to meet the body's needs, requiring dialysis or kidney transplantation.
  • Peritoneal Dialysis: A treatment for kidney failure that uses the lining of your abdomen (peritoneum) and a cleaning solution called dialysate to filter waste and excess fluid from your blood.
  • Kt/V urea: A measure of dialysis adequacy, where K is the dialyzer clearance, t is the dialysis time, and V is the volume of distribution of urea.
  • Insulin Resistance: A condition in which cells in the body don't respond properly to insulin, leading to high blood sugar levels.
  • HbA1c: Glycated hemoglobin, a form of hemoglobin used to diagnose diabetes and assess long-term blood sugar control.
  • EPO: Erythropoietin, a hormone that stimulates red blood cell production and is often used as a treatment for anemia in kidney disease patients.
  • Ultrafiltration: The process of removing excess fluid from the blood during dialysis.
  • Residual Kidney Function: The remaining ability of damaged kidneys to perform some of their functions, which can be important for the well-being of dialysis patients.

References

  1. http://clinicaltrials.eu/trial/study-on-pravastatins-effect-on-insulin-resistance-in-kidney-transplant-and-chronic-kidney-disease-patients/
  2. http://clinicaltrials.eu/trial/study-on-xylocore-and-drug-combination-for-patients-with-end-stage-kidney-disease-undergoing-peritoneal-dialysis/