Metabolic Factors of Outcomes From Gastric Bypass Surgery (Cassini)

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.

Study Overview

• Status: Terminated
• Conditions: Obesity

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects having gastric bypass (GB) surgery within 4 months of screening visit.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Excess Weight Loss	Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.	16 months
Resting Energy Expenditure	Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.	16 months
Area Under the Curve of Ghrelin and GLP-1	These variables will measure the combined effects of hormone concentration and duration.	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)	These variables will measure the combined effects of hormone concentration and duration.	16 months
Adiponectin and Lectin	These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.	16 months
Subject Questionnaires	The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.	16 months
Area Under the Curve of Glucose	This variable will measure the combined effects of glucose concentration and duration.	16 months
Hemoglobin A1c and Lipid Panel	These laboratory values will be collected at Screening, Visit 8, and Visit 10.	16 months
Body Mass Index	Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.	16 Months
Percent Weight Loss	(Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).	16 Months

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Principal Investigator: David D'Alessio, MD, Veterans Affairs Medical Center, Cincinnati, OH

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (Estimate): May 4, 2011

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Obesity Gastric Bypass Roux en Y
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: CI-10-0004