Gastric Bypass SurgeryNCT01938469
Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
A study testing Liquid Meal and Solid Meal in people with Gastric Bypass Surgery and Obesity, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP). Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Gastric Bypass Surgery, Obesity
- What is being tested?
- Liquid Meal and Solid Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Severely obese patients undergoing gastric bypass surgery (GBP)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Lukes- Roosevelt Hospital- New York Obesity Research Center
New York, New York, 10025
About this study
Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).
Read the detailed description
The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.
Gastric emptying will be measured by the acetaminophen test.
- Conditions
- Gastric Bypass Surgery, Obesity
- Being tested
- Liquid Meal, Solid Meal
- Keywords
- Bariatric, Gastric Bypass, Gastric Banding,, Incretins, glucagon-like peptide-1(GLP-1), gastric inhibitory peptide (GIP)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid MealOther
Solid MealOther
| Study group | Role | What they receive |
|---|---|---|
| Solid Meal | Other | Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1). Receives: Other: Solid Meal |
| Liquid Meal | Other | Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1). Receives: Other: Liquid Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Measured: 1 month before GBP Surgery, and 12-15 months post surgery
Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Measured: 1 month before GBP surgery, and 12-15 months post surgery
Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Measured: 1 month before GBP surgery, 12-15 months post surgery
Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Measured: 1 month before GBP , 12-15 months post GBP
Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Measured: 1 month before GBP, 12-15 months post GBP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Bypass SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Blandine Laferrere, MD, Principal investigator, New York Obesity Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938469
- Sponsor's protocol ID
- 09-117
- Status last verified
- Dec 2016
- First submitted
- 21 Aug 2013
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
- ClinicalTrials.gov ID
- NCT01938469
- Acronym / sponsor ID
- 09-117
- Conditions
- Gastric Bypass Surgery, Obesity
- Keywords
- Bariatric, Gastric Bypass, Gastric Banding,, Incretins, glucagon-like peptide-1(GLP-1), gastric inhibitory peptide (GIP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).
Detailed description
The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.
Gastric emptying will be measured by the acetaminophen test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solid Meal | Other | Other: Solid MealParticipants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1). |
| Liquid Meal | Other | Other: Liquid MealParticipants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severely obese patients undergoing gastric bypass surgery (GBP)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Meal | Other | Liquid Meal |
| Solid Meal | Other | Solid Meal |
Primary outcome
Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time frame: 1 month before GBP Surgery, and 12-15 months post surgery
Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time frame: 1 month before GBP surgery, and 12-15 months post surgery
Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time frame: 1 month before GBP surgery, 12-15 months post surgery
Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time frame: 1 month before GBP , 12-15 months post GBP
Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Time frame: 1 month before GBP, 12-15 months post GBP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
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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.
Blandine Laferrere, MD principal investigator
New York Obesity Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Meal and Solid Meal in people with Gastric Bypass Surgery and Obesity, run by St. Luke's-Roosevelt Hospital Center 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 29 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals. (time frame: 1 month before GBP Surgery, and 12-15 months post surgery). The study lists 5 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 29 Dec 2016.