Obesity
Conditions
Keywords
Obesity Gastric Bypass Roux en Y
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.
Interventions
None listed
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Excess Weight Loss | 16 months | 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 | 16 months | 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 | 16 months | These variables will measure the combined effects of hormone concentration and duration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Glucose | 16 months | This variable will measure the combined effects of glucose concentration and duration. |
| Hemoglobin A1c and Lipid Panel | 16 months | These laboratory values will be collected at Screening, Visit 8, and Visit 10. |
| Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide) | 16 months | These variables will measure the combined effects of hormone concentration and duration. |
| Percent Weight Loss | 16 Months | (Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline). |
| Body Mass Index | 16 Months | Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10. |
| Adiponectin and Lectin | 16 months | These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10. |
| Subject Questionnaires | 16 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Area Under the Curve of Ghrelin and GLP-1
These variables will measure the combined effects of hormone concentration and duration.
Time frame: 16 months
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.
Time frame: 16 months
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.
Time frame: 16 months
Secondary
Adiponectin and Lectin
These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.
Time frame: 16 months
Secondary
Area Under the Curve of Glucose
This variable will measure the combined effects of glucose concentration and duration.
Time frame: 16 months
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.
Time frame: 16 months
Secondary
Body Mass Index
Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.
Time frame: 16 Months
Secondary
Hemoglobin A1c and Lipid Panel
These laboratory values will be collected at Screening, Visit 8, and Visit 10.
Time frame: 16 months
Secondary
Percent Weight Loss
(Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).
Time frame: 16 Months
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.
Time frame: 16 months