Metabolic Factors of Outcomes From Gastric Bypass Surgery

Metabolic Factors of Outcomes From Gastric Bypass Surgery

Patrocinadores

Patrocinador principal: Ethicon Endo-Surgery

Fuente Ethicon Endo-Surgery
Resumen breve

The objective of this study is to determine whether the metabolic, endocrine and energetic response to short term caloric restriction are factors in weight loss in subjects having gastric bypass (GB) surgery.

Estado general Terminated
Fecha de inicio April 2011
Fecha de Terminación March 2012
Fecha de finalización primaria March 2012
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Percent Excess Weight Loss 16 months
Resting Energy Expenditure 16 months
Area Under the Curve of Ghrelin and GLP-1 16 months
Resultado secundario
Medida Periodo de tiempo
Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide) 16 months
Adiponectin and Lectin 16 months
Subject Questionnaires 16 months
Area Under the Curve of Glucose 16 months
Hemoglobin A1c and Lipid Panel 16 months
Body Mass Index 16 Months
Percent Weight Loss 16 Months
Inscripción 1
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria:

Subjects satisfying the following criteria will be considered the screening population and will be eligible for enrollment in this study:

1. Subject is willing to give consent and comply with evaluation and treatment schedule

2. 18 to 65 years of age (inclusive) on date of signing the ICD

3. Subject is scheduled to have non-revisional GB surgery between 2 weeks to 4 months after signing the ICD

4. Able to read, understand, and follow study procedures as outlined in the ICD.

Exclusion Criteria:

Subjects meeting the following criteria will not be eligible for enrollment:

1. Unable or unwilling to attend follow-up visits and examinations

2. Women who are pregnant, nursing at the time of screening, or planning to become pregnant within one year of the GB surgery

3. Clinically active cardiac, renal, hepatic or GI disorders

4. Screening laboratory tests with any of the following:

- alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] ≥ 4 times upper limit of normal (ULN) according to VAMC normal ranges

- AST:ALT > 2:1 according to VAMC normal ranges

- Serum Creatinine ≥ 1.5 times ULN according to VAMC normal ranges

- Blood Urea Nitrogen (BUN) ≥ 1.5 times ULN according to VAMC normal ranges

- Positive test results for Hepatitis A, B or C

5. Clinically active thyroid or lipid disorders:

- Thyroid-stimulating hormone (TSH) flagged as critical value (per VAMC lab normal ranges)

- Triglycerides > 400 mg/dL

6. Anemia:

- Mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) outside normal VAMC range; or

- Hematocrit < 36%

7. Uncontrolled hypertension which required a medication regimen adjustment during the 3 months prior to screening

8. Currently prescribed or taking atypical antipsychotic medication

9. Currently prescribed or taking chronic, long-term, oral corticosteroid medication

10. Diabetes requiring a drug regimen which includes insulin treatment at the time of screening

11. Unwilling or unable to refrain from having a procedure or surgery which involves the removal of skin tissue which could result in weight loss

12. Any medical condition or finding for which the PI used medical discretion to determine the subject should be excluded; or

13. Participation in any other investigational device or drug study (non survey based trial) during the course of the trial.

Género: All

Edad mínima: 18 Years

Edad máxima: 65 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
David D'Alessio, MD Principal Investigator Veterans Affairs Medical Center, Cincinnati, OH
Ubicación
Instalaciones: Veterans Affairs Medical Center
Ubicacion Paises

United States

Fecha de verificación

April 2012

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: All Subjects

Descripción: This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.

Acrónimo Cassini
Información de diseño del estudio

Modelo de observación: Case-Only

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov