NCT01569724

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary cutaneous lymphomas are the second group of extra nodal lymphomas after gastrointestinal lymphomas. Bexarotene is licensed for the treatment of epidermotropic cutaneous T cell lymphoma .The most common side effect of bexarotene is hypertriglyceridemia (82%) associated with hypercholesterolemia (30 to 40%). Central hypothyroidism is also present in 40-80% of cases. These adverse effects are dose-dependent. The management of hyperlipidemia induced by bexarotene is difficult. The mechanism of lipid disorder induced by bexarotene is not well known. Associated carbohydrate metabolism disorder could be present and play a role in the bexarotene-induced hyperlipidemia. The main objective is to estimate the frequency of a carbohydrate disorder in patients with hypertriglyceridemia (TG\> 1.5 g / L) induced by bexarotene treatment of cutaneous T cell lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.

Conditions

• Hypertriglyceridemia
• Cutaneous T Cell Lymphoma

Interventions

Type	Name	Description
OTHER	oral glucose tolerance test (OGTT)	patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-12-01
• Completion: 2017-04-01
• First posted: 2012-04-03
• Last updated: 2017-07-21

Locations

1 site across 1 country: France