Metabolic Factors of Outcomes From Gastric Bypass Surgery (Cassini)

This study has been terminated.
(Study was terminated for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01347840
First received: May 3, 2011
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Metabolic Factors of Outcomes From Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Percent Excess Weight Loss [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    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.

  • Resting Energy Expenditure [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.

  • Area Under the Curve of Ghrelin and GLP-1 [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    These variables will measure the combined effects of hormone concentration and duration.


Secondary Outcome Measures:
  • Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    These variables will measure the combined effects of hormone concentration and duration.

  • Adiponectin and Lectin [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.

  • Subject Questionnaires [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    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.

  • Area Under the Curve of Glucose [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    This variable will measure the combined effects of glucose concentration and duration.

  • Hemoglobin A1c and Lipid Panel [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    These laboratory values will be collected at Screening, Visit 8, and Visit 10.

  • Body Mass Index [ Time Frame: 16 Months ] [ Designated as safety issue: No ]
    Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.

  • Percent Weight Loss [ Time Frame: 16 Months ] [ Designated as safety issue: No ]
    (Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).


Enrollment: 1
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347840

Locations
United States, Ohio
Veterans Affairs Medical Center
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: David D'Alessio, MD Veterans Affairs Medical Center, Cincinnati, OH
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01347840     History of Changes
Other Study ID Numbers: CI-10-0004
Study First Received: May 3, 2011
Results First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ethicon Endo-Surgery:
Obesity Gastric Bypass Roux en Y

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014