Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma

Hypertriglyceridemia Clinical Trial

— TgBEX  

Official title:

Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569724
• Other study ID #: 2010-A23465-21
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2012
• Last updated: July 19, 2017
• Start date: January 2012
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous T Cell Lymphoma
• Hypertriglyceridemia
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Metabolic Diseases

Intervention

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

Locations

Country	Name	City	State
France	Service de dermatologie - Hôpital de Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose intolerance or diabetes	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.	At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Secondary	hypothyroidism	hypothyroidism detection: TSH, free T3 and free T4 measured weekly during the first month and then every 15 days in the second month. Laboratory abnormalities will be evaluated according to the standards of the laboratory of each center.	At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Secondary	response to bexarotene	Response to bexarotene: it is considered partial if the patient has a decrease in injuries between 50% and 90% to total as if it has a lower damage of more than 90%.	At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.