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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

May 3, 2011
April 19, 2012
April 2011
March 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01347840 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Metabolic Factors of Outcomes From Gastric Bypass Surgery
Metabolic Factors of Outcomes From Gastric Bypass Surgery

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Obesity
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01347840
CI-10-0004
No
Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Principal Investigator: David D'Alessio, MD Veterans Affairs Medical Center, Cincinnati, OH
Ethicon Endo-Surgery
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP