Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients
NCT ID: NCT00941382
Last Updated: 2009-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2008-11-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sibutramin-Metformin
Sibutramine-metformin therapy in a single tablet
Sibutramine-Metformin
sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
Sibutramine
Sibutramine monotherapy
Sibutramine
15 mg per day for 180 days
Metformin
Metformin monotherapy
Metformin
Metformin 850 mg per day for 180 days
Interventions
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Metformin
Metformin 850 mg per day for 180 days
Sibutramine-Metformin
sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
Sibutramine
15 mg per day for 180 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both genders
* BMI between 30 and 40
* Stable body weigh defined by over 5 per cent variability during the previous 3 months
* Fasting serum glucose less than 126 mg per dl
* Blood pressure over 140 and 90 mmHg
* Women ensuring contraceptive precautions.
* Communication and understanding capability.
* Informed consent awarding.
Exclusion Criteria
* Any smoking during the preceding 6 months
* No physical activity, defined by less than 15 minutes per day of walking
* Excessive physical activity equivalent to running over 60 minutes per day
* Known hypersensitivity to sibutramine or metformin
* Low commitment to follow the protocol statements
* Any investigational medication during the preceding 6 months
* Any drug or substance mayor toxicity exposure during the preceding 3 months
* Alcohol or any drug abuse during the previous 3 months
* Current medication of oral corticosteroids, anticoagulants, sympathomimetics, sympatholytics, lipid lowering drugs, any medication for type 2 diabetes, and any sibutramine interaction drug
* Current or previous evidence of ischemic heart disease, cardiac arrhythmia, cerebrovascular disease, chronic hepatic disease, two fold persistent elevation of ALT, AST or FA
* Carrying a pacemaker or any permanent bioelectronic component that could interfere with bioimpedance process
* Renal failure defined by serum creatinine equal or ever 1.2 mg per dL
* Not controlled thyroid disease defined by altered serum T3, T4 and TSH during the previous 3 months
* Hypertension
* Type 2 diabetes
* Anti-depressants, or any psychiatric disturbance treatment
30 Years
50 Years
ALL
No
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Laboratorios Silanes S.A. de C.V.
Principal Investigators
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Jorge A González-Canudas, MD
Role: STUDY_DIRECTOR
Laboratorios Silanes
Manuel González-Ortiz, PHD
Role: STUDY_CHAIR
University of Guadalajara
ESperanza Martínez-Abundis, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico
Countries
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References
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Cachofeiro V. Obesidad, Inflamación y disfunción endotelial. Rev Esp Obes 4: 194-204, 2006.
Ferrannini E, Mari A. How to measure insulin sensitivity. J Hypertens. 1998 Jul;16(7):895-906. doi: 10.1097/00004872-199816070-00001.
Lyle WG; Plastic Surgery Educational Foundation DATA Committee. Pharmacological treatment of obesity. Plast Reconstr Surg. 2002 Nov;110(6):1577-80. doi: 10.1097/01.PRS.0000028331.84171.86. No abstract available.
Luque CA, Rey JA. The discovery and status of sibutramine as an anti-obesity drug. Eur J Pharmacol. 2002 Apr 12;440(2-3):119-28. doi: 10.1016/s0014-2999(02)01423-1.
Weigle DS. Pharmacological therapy of obesity: past, present, and future. J Clin Endocrinol Metab. 2003 Jun;88(6):2462-9. doi: 10.1210/jc.2003-030151. No abstract available.
Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs. 2003;63(18):1879-94. doi: 10.2165/00003495-200363180-00001.
Bloomgarden ZT. Metformin. Diabetes Care. 1995 Jul;18(7):1078-80. doi: 10.2337/diacare.18.7.1078. No abstract available.
Campbell I. The obesity epidemic: can we turn the tide? Heart. 2003 May;89 Suppl 2(Suppl 2):ii22-4; discussion ii35-7. doi: 10.1136/heart.89.suppl_2.ii22.
McNulty SJ, Ur E, Williams G; Multicenter Sibutramine Study Group. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. Diabetes Care. 2003 Jan;26(1):125-31. doi: 10.2337/diacare.26.1.125.
Love-Osborne K, Sheeder J, Zeitler P. Addition of metformin to a lifestyle modification program in adolescents with insulin resistance. J Pediatr. 2008 Jun;152(6):817-22. doi: 10.1016/j.jpeds.2008.01.018. Epub 2008 Mar 19.
Gonzalez-Ortiz M, Martinez-Abundis E, Mora-Martinez JM, Grover-Paez F. Renal handling of uric acid assessed by means of pharmacological tests in obese women. Diabetes Nutr Metab. 2001 Aug;14(4):189-94.
Clement K, Ferre P. Genetics and the pathophysiology of obesity. Pediatr Res. 2003 May;53(5):721-5. doi: 10.1203/01.PDR.0000059753.61905.58. Epub 2003 Mar 5.
Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
Lozano Castañeda O. Adipocitoquinas. Rev Endocr Nutr. 10: 147-50, 2002.
Karnehed N, Rasmussen F, Hemmingsson T, Tynelius P. Obesity and attained education: cohort study of more than 700,000 Swedish men. Obesity (Silver Spring). 2006 Aug;14(8):1421-8. doi: 10.1038/oby.2006.161.
Hensrud DD, Klein S. Extreme obesity: a new medical crisis in the United States. Mayo Clin Proc. 2006 Oct;81(10 Suppl):S5-10. doi: 10.1016/s0025-6196(11)61175-0.
Other Identifiers
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OB Sil-02
Identifier Type: -
Identifier Source: org_study_id
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