Clinical trial NCT01347840: Metabolic Factors of Outcomes From Gastric Bypass Surgery
Official title: Metabolic Factors of Outcomes From Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Obesity Gastric Bypass Roux en Y
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects having gastric bypass (GB) surgery within 4 months of screening visit.

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.


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.

Primary outcomes:
measure: Percent Excess Weight Loss
timeFrame: 16 months
measure: Resting Energy Expenditure
timeFrame: 16 months
measure: Area Under the Curve of Ghrelin and GLP-1
timeFrame: 16 months
Secondary outcomes:
measure: Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)
timeFrame: 16 months
measure: Adiponectin and Lectin
timeFrame: 16 months
measure: Subject Questionnaires
timeFrame: 16 months
measure: Area Under the Curve of Glucose
timeFrame: 16 months
measure: Hemoglobin A1c and Lipid Panel
timeFrame: 16 months
measure: Body Mass Index
timeFrame: 16 Months
measure: Percent Weight Loss
timeFrame: 16 Months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Veterans Affairs Medical Center
state: Ohio
Study officials:
affiliation: Veterans Affairs Medical Center, Cincinnati, OH
name: David D'Alessio, MD
role: PRINCIPAL_INVESTIGATOR
References: