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

NCT01569724 | Completed Phase 4

• 1 other identifier: 2010-A23465-21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertriglyceridemia; Cutaneous T Cell Lymphoma

Keywords

hypertriglyceridemia; bexarotene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• hypothyroidism

  At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.

• response to bexarotene

  At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.

Study Arms (1)

bexarotene

EXPERIMENTAL

Other: oral glucose tolerance test (OGTT)

Interventions

oral glucose tolerance test (OGTT) OTHER

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

Also known as: Non applicable.

bexarotene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Service de dermatologie - Hôpital de Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Lymphoma, T-Cell, Cutaneous

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Henri ADAMSKI, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• Emmanuel OGER, MD, PhD

  Rennes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: April 3, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

FR (1)