Metabolic Factors of Outcomes From Gastric Bypass Surgery

NCT01347840 | Terminated Results

• 1 other identifier: CI-10-0004
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity Gastric Bypass Roux en Y

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)

  16 months

• Adiponectin and Lectin

  16 months

• Subject Questionnaires

  16 months

• Area Under the Curve of Glucose

  16 months

• Hemoglobin A1c and Lipid Panel

  16 months

Study Arms (1)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subjects satisfying the following criteria will be considered the screening population and will be eligible for enrollment in this study:
• Subject is willing to give consent and comply with evaluation and treatment schedule
• to 65 years of age (inclusive) on date of signing the ICD
• Subject is scheduled to have non-revisional GB surgery between 2 weeks to 4 months after signing the ICD
• Able to read, understand, and follow study procedures as outlined in the ICD.

You may not qualify if:

• Subjects meeting the following criteria will not be eligible for enrollment:
• Unable or unwilling to attend follow-up visits and examinations
• Women who are pregnant, nursing at the time of screening, or planning to become pregnant within one year of the GB surgery
• Clinically active cardiac, renal, hepatic or GI disorders
• 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
• Clinically active thyroid or lipid disorders:
• Thyroid-stimulating hormone (TSH) flagged as critical value (per VAMC lab normal ranges)
• Triglycerides \> 400 mg/dL
• Anemia:
• Mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) outside normal VAMC range; or

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

Veterans Affairs Medical Center

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Trial termination due to business needs. One subject enrolled and withdrew consent. Zero subjects completed study. No subject data analyzed.

Results Point of Contact

• Title: Amy Mahanes
• Organization: Ethicon Endo-Surgery, Inc.

amahanes@its.jnj.com

513-337-8366

Study Officials

• David D'Alessio, MD

  Veterans Affairs Medical Center, Cincinnati, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 21, 2012
• Results First Posted: May 21, 2012

Record last verified: 2012-04

Locations

US (1)