Insulin Resistant Human Obesity
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Product Code: cA2
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis
Sponsors
Med. Universitaetsklinik Graz, ao Univ. Professor Dr. med. Thomas C. Wascher
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects to be included must meet the following criteria: 1. Men between 20 and 50 years of age. 2. BMI between and including 30 and 35 kg/m2 3. HOMA index > 2.5 4. History of stable weight (+/- 2 kg) > 3 months 5. Blood pressure > 135 / 85 mmHg (or treated hypertension) 6. Triglycerides > 1.7 mmol/l or HDL-cholesterol = 8.5 g/dL b. WBC >= 3.5 x 10 hoch 9/L c. Neutrophils >= 1.5 x 10 hoch 9/L d. Platelets >= 100 x 10 hoch 9/L e. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test. 9. Subject must be able to adhere to the study visit schedule and other protocol requirements. 10. The subject must be capable of giving informed consent and the consent must be obtained prior to any screening procedures. 11. Must have a chest radiograph within 3 months prior to first infusion with no evidence of malignancy, infection or fibrosis. 12. Are considered eligible according to the following tuberculosis (TB) screening criteria: a. Have no history of latent or active TB prior to screening. b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent. d. Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, as outlined in Appendix B, or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from this study for any of the following reasons: 1. Patients with overt diabetes (fasting glucose > 7.0 mmol/l). 2. Current treatment with angiotensin II antagonists or ACE inhibitors. 3. Treatment indication with statins according to the current NCEP III criteria. 4. Treatment indication with low dose acetylsalicylic acid according to the current AHA quidelines or any other NSAID. 5. Current smokers. 6. Patients with (a history of) an autoimmune disease. 7. Use of any investigational drug within 1 month prior to screening or within 5 half- lives of the investigational agent, whichever is longer. 8. Treatment with any other therapeutic agent targeted at reducing TNFa (eg, pentoxifylline, thalidomide, etanercept, adalimumab) within 3 months of screening. 9. Previous administration of infliximab. 10. History of receiving human/murine recombinant products or known allergy to murine products. 11. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator. 12. Documented HIV infection. 13. Active hepatitis- B or antibodies against hepatitis-C 14. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. 15. Have or have had a opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis,) within 6 months prior to screening. 16. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis). 17. Concomitant congestive heart failure, including medically controlled asymptomatic patients. 18. Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening). 19. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). 20. History of lymphoproliferative disease including lymphoma, or sign and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly. 21. Known recent substance abuse (drug or alcohol). 22. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period. 23. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening. 24. Have a chest radiograph within 3 months prior to randomization that shows an abnormality suggestive of a malignancy or current active infection, including TB.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of the study are to test whether neutralizing TNF-a with infliximab affects insulin resistance and phenotypical manifestations of the metabolic syndrome such as: - Fasting plasma insulin - Iv-GTT derived parameters of insulin resistance and ß-cell function - Total body fat - Plasma lipid profile - Vascular endothelial dysfunction - Circulating markers of inflammation and endothelial dysfunction ;Secondary Objective: not defined;Primary end point(s): The primary endpoint in this study is the change in fasting insulin levels between base line levels (day 0) and day 70. | — |
Countries
Austria
Outcome results
None listed