ObesityCassiniNCT01347840
Metabolic Factors of Outcomes From Gastric Bypass Surgery
An observational study of Obesity, run by Ethicon Endo-Surgery at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects having gastric bypass (GB) surgery within 4 months of screening visit.
Who may be able to join
- 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
- 18 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
- Hematocrit < 36%
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center
Cincinnati, Ohio, 45267
About this study
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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 months
Area Under the Curve of Ghrelin and GLP-1
These variables will measure the combined effects of hormone concentration and duration.
Measured: 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)
These variables will measure the combined effects of hormone concentration and duration.
Measured: 16 months
Adiponectin and Lectin
These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.
Measured: 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.
Measured: 16 months
Area Under the Curve of Glucose
This variable will measure the combined effects of glucose concentration and duration.
Measured: 16 months
Hemoglobin A1c and Lipid Panel
These laboratory values will be collected at Screening, Visit 8, and Visit 10.
Measured: 16 months
Body Mass Index
Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.
Measured: 16 Months
Percent Weight Loss
(Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).
Measured: 16 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Study was terminated for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David D'Alessio, MD, Principal investigator, Veterans Affairs Medical Center, Cincinnati, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347840
- Sponsor's protocol ID
- CI-10-0004
- Acronym
- Cassini
- Status last verified
- Apr 2012
- First submitted
- 3 May 2011
- Last updated
- 21 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Factors of Outcomes From Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01347840
- Acronym / sponsor ID
- Cassini / CI-10-0004
- Conditions
- Obesity
- Keywords
- Obesity Gastric Bypass Roux en Y
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated for business reasons.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Posted 21 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects having gastric bypass (GB) surgery within 4 months of screening visit.
Key inclusion criteria (5 listed)
- 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
- 18 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.
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Excess Weight Loss
Time frame: 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
Time frame: 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
Time frame: 16 months
These variables will measure the combined effects of hormone concentration and duration.
7 secondary outcomes
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
Adiponectin and Lectin
Time frame: 16 months
Subject Questionnaires
Time frame: 16 months
Area Under the Curve of Glucose
Time frame: 16 months
Hemoglobin A1c and Lipid Panel
Time frame: 16 months
Body Mass Index
Time frame: 16 Months
Percent Weight Loss
Time frame: 16 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David D'Alessio, MD principal investigator
Veterans Affairs Medical Center, Cincinnati, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Ethicon Endo-Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Excess Weight Loss (time frame: 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2012.