Characterizing lipodystrophy (CLEAR)

Clinical Lipodystrophy Evaluation And Registration - Clinical Lipodystrophy Evaluation And Registration

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58431

Enrollment

500

Registered

2025-12-02

Start date

2026-03-06

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipodystrophy Lipodystrophy

Interventions

n.v.t.

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must be referred to the LUMC for confirmation of lipodystrophy or be already diagnosed with lipodystrophy.

Exclusion criteria

Exclusion criteria: As this is merely an observational registry on current procedures, no exclusion criteria are used.

Design outcomes

Primary

Measure	Time frame
The primary outcome of this research is the prevalence of all the different lipodystrophy subtypes (e.g., familial partial lipodystrophy, congenital generalized lipodystrophy, and acquired forms) among patients at the LUMC.	—

Secondary

Measure	Time frame
Secondary study parameters are: General history and clinical course, including age of onset, progression, comorbidities, and metabolic and organ-related complications (e.g., diabetes mellitus, dyslipidaemia, hepatic steatosis, cardiovascular events).Metabolic outcomes (e.g., glucose, HbA1c, lipid levels, liver enzymes, and other markers of insulin resistance over time).Hepatic steatosis, measured with liver ultrasound or Fibroscan.Diagnostic delay, defined as the time between the first documented abnormal metabolic or clinical finding and final lipodystrophy diagnosis.Quality of life, measured with questionnaires taken during regular care.Healthcare utilization, including number and type of specialist visits, hospitalizations, diagnostic tests, and medications prior to and after diagnosis.The response to various treatment options that are currently available and those that will be available in the future (e.g., diet, lifestyle, medication).Morbidity and mortality, including presence and timing of major complications and, where applicable, cause and age of death.Genotype-phenotype correlations.Predictive value of early clinical/laboratory features, assessed retrospectively to identify patterns that could have supported earlier diagnosis.	—

Measure

Time frame

Secondary study parameters are: General history and clinical course, including age of onset, progression, comorbidities, and metabolic and organ-related complications (e.g., diabetes mellitus, dyslipidaemia, hepatic steatosis, cardiovascular events).Metabolic outcomes (e.g., glucose, HbA1c, lipid levels, liver enzymes, and other markers of insulin resistance over time).Hepatic steatosis, measured with liver ultrasound or Fibroscan.Diagnostic delay, defined as the time between the first documented abnormal metabolic or clinical finding and final lipodystrophy diagnosis.Quality of life, measured with questionnaires taken during regular care.Healthcare utilization, including number and type of specialist visits, hospitalizations, diagnostic tests, and medications prior to and after diagnosis.The response to various treatment options that are currently available and those that will be available in the future (e.g., diet, lifestyle, medication).Morbidity and mortality, including presence and timing of major complications and, where applicable, cause and age of death.Genotype-phenotype correlations.Predictive value of early clinical/laboratory features, assessed retrospectively to identify patterns that could have supported earlier diagnosis.

—

Countries

Netherlands

Contacts

Public ContactI.M. Jazet

Leids Universitair Medisch Centrum

i.m.jazet@lumc.nl0715263082

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026