Metabolic Factors of Outcomes From Gastric Bypass Surgery

Obesity Clinical Trial

— Cassini  

Official title:

Metabolic Factors of Outcomes From Gastric Bypass Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01347840
• Other study ID #: CI-10-0004
• Status: Terminated
• Phase: N/A
• First received: May 3, 2011
• Last updated: April 19, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Area Under the Curve of Ghrelin and GLP-1	These variables will measure the combined effects of hormone concentration and duration.	16 months	No
Secondary	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	No
Secondary	Adiponectin and Lectin	These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.	16 months	No
Secondary	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	No
Secondary	Area Under the Curve of Glucose	This variable will measure the combined effects of glucose concentration and duration.	16 months	No
Secondary	Hemoglobin A1c and Lipid Panel	These laboratory values will be collected at Screening, Visit 8, and Visit 10.	16 months	No
Secondary	Body Mass Index	Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.	16 Months	No
Secondary	Percent Weight Loss	(Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).	16 Months	No