Clinical trial · Interventional
Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma
Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study
NCT01569724CI-TRIAL-00028711TgBEXcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Hypertriglyceridemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral glucose tolerance test (OGTT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bexarotene
- interventionNames
- Other: oral glucose tolerance test (OGTT)
Primary outcomes (1)
- measure
- glucose intolerance or diabetes
- timeFrame
- At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
- description
- The presence of a carbohydrate disorder is defined by glucose intolerance or diabetes. The diagnosis of glucose intolerance is made for a fasting glucose less than 1.26 g / l glucose and 2 hours (T120mn) after taking 75 g of glucose during an oral glucose tolerance test (OGTT) between 1.4 and 2 g / l and / or a value greater than or equal to 2 g / l between T30 and T90 min. Diabetes is established for a fasting glucose greater than or equal to 1.26 g / l and / or blood glucose greater than or equal to 2 g / l to 2 hours.
Secondary outcomes (2)
- measure
- hypothyroidism
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged over 18 years * Diagnosis of epidermotropic CTCL confirmed by histological examination for which consideration will be given treatment with bexarotene due to the advanced stage of lymphoma (stage IIB-IV) or earlier stage if resistance to previous treatment . * TSH, FT3 and FT4 within normal limits * AST and ALT ≤ 2 \* upper limit of normal * Creatinine clearance ≥ 30 mL / min * Agreement after written information and informed to participate in the study * Patient accepting the constraints of the study * Membership of a social security system. Exclusion Criteria: * Pregnant or lactating woman * Women of childbearing potential without effective contraception * Insufficient thyroid or hyperthyroidism * Diabetes known or detected * Hyperlipidemia known or detected * Hepatic insufficiency * Difficulties to understand * Persons covered by a plan of legal protection (protection of justice, guardianship, curator) or unable to issue a consent
References
Publications (0)
Data not yet available
No reference posted for this study.