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Study was terminated for business reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adiponectin and Lectin |
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Inclusion Criteria:
Subjects satisfying the following criteria will be considered the screening population and will be eligible for enrollment in this study:
Exclusion Criteria:
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:
Clinically active thyroid or lipid disorders:
Anemia:
Uncontrolled hypertension which required a medication regimen adjustment during the 3 months prior to screening
Currently prescribed or taking atypical antipsychotic medication
Currently prescribed or taking chronic, long-term, oral corticosteroid medication
Diabetes requiring a drug regimen which includes insulin treatment at the time of screening
Unwilling or unable to refrain from having a procedure or surgery which involves the removal of skin tissue which could result in weight loss
Any medical condition or finding for which the PI used medical discretion to determine the subject should be excluded; or
Participation in any other investigational device or drug study (non survey based trial) during the course of the trial.
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Subjects having gastric bypass (GB) surgery within 4 months of screening visit.
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| Name | Affiliation | Role |
|---|---|---|
| David D'Alessio, MD | Veterans Affairs Medical Center, Cincinnati, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center | Cincinnati | Ohio | 45267 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of excess weight | 16 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Trial termination due to business needs. One subject enrolled and withdrew consent. Zero subjects completed study. No subject data analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Mahanes | Ethicon Endo-Surgery, Inc. | 513-337-8366 | amahanes@its.jnj.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10. |
| 16 months |
| 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 |
| Area Under the Curve of Glucose | This variable will measure the combined effects of glucose concentration and duration. | 16 months |
| Hemoglobin A1c and Lipid Panel | These laboratory values will be collected at Screening, Visit 8, and Visit 10. | 16 months |
| Body Mass Index | Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10. | 16 Months |
| Percent Weight Loss | (Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline). | 16 Months |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Posted | Number | units on a scale | 16 months |
|
|
| Primary | Area Under the Curve of Ghrelin and GLP-1 | These variables will measure the combined effects of hormone concentration and duration. | Posted | Number | units on a scale | 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. | Posted | Number | units on a scale | 16 months |
|
|
| Secondary | Adiponectin and Lectin | These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10. | Posted | Number | units on a scale | 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. | Posted | Number | participants | 16 months |
|
|
| Secondary | Area Under the Curve of Glucose | This variable will measure the combined effects of glucose concentration and duration. | Posted | Number | units on a scale | 16 months |
|
|
| Secondary | Hemoglobin A1c and Lipid Panel | These laboratory values will be collected at Screening, Visit 8, and Visit 10. | Posted | Number | units on a scale | 16 months |
|
|
| Secondary | Body Mass Index | Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10. | Posted | Number | units on a scale | 16 Months |
|
|
| Secondary | Percent Weight Loss | (Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline). | Posted | Number | percentage of weight loss | 16 Months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |