- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00623545
Bioenergetic Alterations After Exenatide Administration
Descripción general del estudio
Descripción detallada
The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories.
Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible. Women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study.
Subjects will take exenatide for 12 weeks. There are 6 study visits in the Univ. Wisconsin Hospital General Clinical Research Center. Visits range from 1 to 6 hours and include blood and urine tests, resting metabolic rate testing over a four hour period, physical exam, ECG, and a be bone mineral density testing at another clinic during 2 clinic visits of the study.
All study procedures and testing are free of charge.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Madison., Wisconsin, Estados Unidos, 53792
- Univ Wisconsin Hospital and Clinics
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18-65 years of age
- BMI between 30 and 40 kg/m2
- Women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception
- Absence of weight change greater than 3 kg in the previous 6 months
Exclusion Criteria:
- Women who are pregnant or lactating
- Current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program
- Use of weight loss medication
- A history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study
- Presence of medical conditions that are known to affect energy expenditure (i.e. hyperthyroidism, rheumatoid arthritis, AIDS among others)
- History of hypoglycemia
- A history of psychiatric or eating disorder
- Abnormal EKG
- Previous history of pancreatitis
- Previous history of gastroparesis or GI motility disorder
- Use of medications that can affect GI motility
- History of organ transplantation
- Other comorbid conditions which may preclude the subject's ability to complete the study
- Use of a carbonic anhydrase inhibitor such as acetazolamide
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exenatide
Exenatide.
Dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks Each subject serves as their own control for outcome measures taken before and during drug treatment.
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Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Energy Intake Measured Before Treatment and at the End of Treatment.
Periodo de tiempo: 3 months
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Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment.
Units are kcal/d.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weight Loss After Administration of Exenatide.
Periodo de tiempo: 3 months
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Body weight after overnight fast in light clothing
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3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David P Bradley, MD, University of Wisconsin, Madison
Publicaciones y enlaces útiles
Publicaciones Generales
- Bradley DP, Kulstad R, Schoeller DA. Exenatide and weight loss. Nutrition. 2010 Mar;26(3):243-9. doi: 10.1016/j.nut.2009.07.008.
- Bradley DP, Kulstad R, Racine N, Shenker Y, Meredith M, Schoeller DA. Alterations in energy balance following exenatide administration. Appl Physiol Nutr Metab. 2012 Oct;37(5):893-9. doi: 10.1139/h2012-068. Epub 2012 Jun 26.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-2007-0235
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