Metabolic Factors of Outcomes From Gastric Bypass Surgery

Stopped early

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT01347840

Run by

Ethicon Endo-Surgery

People needed

1

Starts

2011-04-01

Expected to finish

2012-03-01

Last updated by the study team

2012-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects satisfying the following criteria will be considered the screening population and will be eligible for enrollment in this study:
• Subject is willing to give consent and comply with evaluation and treatment schedule
• 18 to 65 years of age (inclusive) on date of signing the ICD
• Subject is scheduled to have non-revisional GB surgery between 2 weeks to 4 months after signing the ICD
• Able to read, understand, and follow study procedures as outlined in the ICD.

You may not qualify if…

• Subjects meeting the following criteria will not be eligible for enrollment:
• Unable or unwilling to attend follow-up visits and examinations
• Women who are pregnant, nursing at the time of screening, or planning to become pregnant within one year of the GB surgery
• Clinically active cardiac, renal, hepatic or GI disorders
• 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
• Clinically active thyroid or lipid disorders:
• Thyroid-stimulating hormone (TSH) flagged as critical value (per VAMC lab normal ranges)
• Triglycerides > 400 mg/dL
• Anemia:
• Mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) outside normal VAMC range; or
• Hematocrit < 36%
• Uncontrolled hypertension which required a medication regimen adjustment during the 3 months prior to screening
• Currently prescribed or taking atypical antipsychotic medication
• Currently prescribed or taking chronic, long-term, oral corticosteroid medication
• Diabetes requiring a drug regimen which includes insulin treatment at the time of screening
• Unwilling or unable to refrain from having a procedure or surgery which involves the removal of skin tissue which could result in weight loss
• Any medical condition or finding for which the PI used medical discretion to determine the subject should be excluded; or
• Participation in any other investigational device or drug study (non survey based trial) during the course of the trial.

Where it is running

• Veterans Affairs Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.