Gallbladder Disease
Definition
Gallstones and cholecystitis, which appear more often in trials of GLP-1 receptor agonists than on placebo. The usual explanation is the rapid reduction in body weight participants in those studies undergo, which is itself a gallstone risk factor independently of any drug.
Terms used in this definition
Other entries this definition refers to.
What this means for research sourcing
Volta compounds are research chemicals not intended for human consumption; safety terminology here is provided for research literacy.
Related Terms in Clinical & Safety
MedWatch
The FDA's programme for reporting adverse events and product problems, open to clinicians and to the public. It is the input side of US pharmacovigilance, and its reports are voluntary, which is why counts from it understate.
REMS (Risk Evaluation and Mitigation Strategy)
An FDA-mandated safety programme for a drug whose risks need managing beyond its label, through prescriber certification, documented patient acknowledgement or restricted distribution.
Body Mass Index (BMI)
Weight in kilograms divided by height in metres squared, used in trials as an entry criterion and a reported characteristic. It does not distinguish one tissue type from another, which is why body composition is measured separately.
Fasting Plasma Glucose
Blood glucose measured after a defined period without food, a standard endpoint in metabolic trials. It describes one moment, which is why it is usually reported alongside HbA1c.
Glycaemic Control
How closely blood glucose is held within a target range over time, assessed from HbA1c, fasting glucose and postprandial measurements together. It is the composite endpoint most incretin trials are designed around.
hs-CRP
High-sensitivity C-reactive protein, a blood marker of systemic inflammation measured by an assay able to resolve the low end of the range. It is non-specific: a raised value indicates inflammation without indicating its source.
Triglycerides
The main form fat is stored and transported in, measured in a standard lipid panel. It is reported as a metabolic endpoint and is sensitive to how recently the sample was taken relative to eating.
Postprandial
Occurring after a meal. Postprandial glucose and lipid measurements describe the response to a challenge, which is a different question from the fasting value and often a more sensitive one.
