Metabolic Factors of Outcomes From Gastric Bypass Surgery

NCT ID: NCT01347840

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-03-31

Brief Summary

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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All Subjects

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David D'Alessio, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Affairs Medical Center, Cincinnati, OH

Locations

Veterans Affairs Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

CI-10-0004

Identifier Type: -

Identifier Source: org_study_id