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Related Concept Videos

Drug Dosing: Obese Patients01:21

Drug Dosing: Obese Patients

In the United States, obesity is a prominent concern. It is linked to heightened mortality rates due to increased occurrences of conditions such as hypertension, atherosclerosis, coronary artery disease, and diabetes compared to nonobese individuals. A patient is classified as obese if their actual body weight surpasses the ideal or desirable body weight by 20%, based on Metropolitan Life Insurance Company data. Ideal body weights consider average weights and heights for males and females...
Pharmacokinetics in Obese Patients: Drug Absorption and Distribution01:25

Pharmacokinetics in Obese Patients: Drug Absorption and Distribution

Obesity significantly alters the pharmacokinetic processes of drug absorption and distribution, presenting unique challenges in medical treatment. The increased fat tissue and decreased lean muscle in obese individuals can significantly affect how drugs are absorbed into the body and distributed across different tissues. This alteration can lead to variances in the effectiveness and safety of medications, necessitating adjustments in dosing or drug selection for obese patients.One notable...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Pharmacokinetics in Obese Patients: Drug Metabolism and Excretion01:20

Pharmacokinetics in Obese Patients: Drug Metabolism and Excretion

Drug metabolism, a critical process in the liver, involves two primary phases: Phase I reactions and Phase II conjugation. Obesity introduces significant alterations in this metabolic process, primarily due to fatty infiltration of the liver, leading to conditions such as nonalcoholic fatty liver disease (NAFLD). This condition can modify the activities of both Phase I and II enzymes, impacting how drugs are metabolized in obese patients.Phase I metabolism sees variable effects across...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Obesity01:24

Obesity

The Body Mass Index (BMI) is a numerical value derived from a person's weight and height, used to categorize individuals into weight ranges. It is calculated using the formula: weight in kilograms divided by height in meters squared. Obesity is a health condition characterized by excessive accumulation of adipose tissue that poses health risks, often diagnosed with a BMI ≥ 30. This excess fat storage occurs when surplus dietary calories are converted into triglycerides and stored in adipocytes...

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Related Experiment Video

Updated: Jun 21, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Sample size in obesity trials: patient perspective versus current practice.

David B Allison1, Mai A Elobeid, Mark B Cope

  • 1Department of Nutrition Sciences and the Clinical Nutrition Research Center, University of Alabama at Birmingham, Birmingham, AL 35294, USA. dallison@uab.edu

Medical Decision Making : an International Journal of the Society for Medical Decision Making
|August 14, 2009
PubMed
Summary

Patients desire minimal risk for weight loss in clinical trials. Current obesity randomized clinical trials (RCTs) require tens of thousands of participants to detect risks meaningful to patients.

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Area of Science:

  • Clinical Research
  • Obesity Medicine
  • Biostatistics

Background:

  • Determining acceptable risk is crucial for patient informed consent in obesity randomized clinical trials (RCTs).
  • Patient perceptions of risk versus reward significantly impact trial design and feasibility.

Purpose of the Study:

  • To assess patient willingness to accept risks for weight loss in obesity RCTs.
  • To evaluate the implications of patient risk tolerance on sample size calculations for obesity RCTs.

Main Methods:

  • A survey was administered to patients entering weight loss RCTs at a university research setting.
  • Participants reported acceptable risk of serious adverse events (SAEs) or death for specific weight loss.
  • Power calculations were performed based on patient responses and trial parameters.

Main Results:

  • Patients indicated a mean acceptable risk of approximately 3.5% for 5-10% weight loss, but median and mode suggested <1% risk tolerance.
  • Detecting patient-meaningful risks in 1-year obesity RCTs necessitates tens of thousands of participants per group.

Conclusions:

  • Patient education on realistically detectable risks in RCTs is vital for informed consent.
  • Obesity RCT standards may need adjustment to align with patient risk expectations.