Morbid ObesityLAF 28NCT02929212
Effect of Number of Meals on Metabolism After Weight Loss Surgery
A study testing Solid Meal, Liquid Meal and Acetaminophen in people with Morbid Obesity, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Solid Meal, Liquid Meal and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 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
None listed.
Who cannot join
- Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
- Patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome.
- Currently pregnant or nursing.
- Known cardiovascular disease.
- Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
- Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
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- past history of severe food allergy
- History of Type 1 Diabetes Mellitus
- Individuals taking insulin, thiazolidinedione, exenatide, or DPP-IV inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.
Read the detailed description
The main goal is to study the effect of meal size and texture on 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 meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) 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.
Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.
- Conditions
- Morbid Obesity
- Being tested
- Solid Meal, Liquid Meal, Acetaminophen, Single, 600 kcal meal, Multiple, 200 kcal meals
- Keywords
- Gastric Bypass, Meal Texture, Meal Number, GLP-1, Glucose
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid MealOther
Subjects will receive solid meals during meal study
Liquid MealOther
Subjects will receive liquid meals, during meal study
AcetaminophenDrug
All subjects given acetaminophen to measure gastric emptying
Single, 600 kcal mealOther
Subjects will receive a single, 600 kcal meal during meal study
Multiple, 200 kcal mealsOther
Subjects will receive three, 200 kcal meals, during meal study
| Study group | Role | What they receive |
|---|---|---|
| Solid Meal Study Group A | Other | Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal. Receives: Other: Solid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal |
| Liquid Meal Study Group A | Other | Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal Receives: Other: Liquid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal |
| Solid Meal Study Group B | Other | Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals. Receives: Other: Solid Meal; Drug: Acetaminophen; Other: Multiple, 200 kcal meals |
| Liquid Meal Study Group B | Other | Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals. Receives: Other: Liquid Meal; Drug: Acetaminophen; Other: Multiple, 200 kcal meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in GLP-1 levels before and after gastric bypass surgery
Investigators will assess GLP-1 levels in subjects pre and post-GBP
Measured: 12-15 months
Difference in glucose levels before and after gastric bypass surgery
Investigators will assess glucose in subjects pre and post-GBP
Measured: 12-15 months
Difference in insulin levels before and after gastric bypass surgery
Investigators will assess insulin levels in subjects pre and post-GBP
Measured: 12-15 months
Secondary outcomes (3)
Difference in GLP-1 levels in solid vs liquid meals
Investigators will assess GLP-1 levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points
Measured: 12-15 months
Difference in glucose levels in solid vs liquid meals
Investigators will assess glucose levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points
Measured: 12-15 months
Difference in insulin levels in solid vs liquid meals
Investigators will assess insulin levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startSep 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blandine Laferrere, Columbia University
- Investigators
- Blandine Laferrere, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929212
- Sponsor's protocol ID
- AAAO3051
- Other IDs
- R01DK067561
- Acronym
- LAF 28
- Status last verified
- Jan 2017
- First submitted
- 7 Oct 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Number of Meals on Metabolism After Weight Loss Surgery
- ClinicalTrials.gov ID
- NCT02929212
- Acronym / sponsor ID
- LAF 28 / AAAO3051
- Conditions
- Morbid Obesity
- Keywords
- Gastric Bypass, Meal Texture, Meal Number, GLP-1, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Oct 2016 (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.
The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.
Detailed description
The main goal is to study the effect of meal size and texture on 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 meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) 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.
Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solid Meal Study Group A | Other | Other: Solid Meal, Drug: Acetaminophen, Other: Single, 600 kcal mealPatients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal. |
| Liquid Meal Study Group A | Other | Other: Liquid Meal, Drug: Acetaminophen, Other: Single, 600 kcal mealPatients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal |
| Solid Meal Study Group B | Other | Other: Solid Meal, Drug: Acetaminophen, Other: Multiple, 200 kcal mealsPatients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals. |
| Liquid Meal Study Group B | Other | Other: Liquid Meal, Drug: Acetaminophen, Other: Multiple, 200 kcal mealsPatients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
- Patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome.
- Currently pregnant or nursing.
- Known cardiovascular disease.
- Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
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 |
|---|---|---|
| Solid MealSubjects will receive solid meals during meal study | Other | Solid Meal Study Group A, Solid Meal Study Group B |
| Liquid MealSubjects will receive liquid meals, during meal study | Other | Liquid Meal Study Group A, Liquid Meal Study Group B |
| AcetaminophenAll subjects given acetaminophen to measure gastric emptying | Drug | Liquid Meal Study Group A, Liquid Meal Study Group B, Solid Meal Study Group A, Solid Meal Study Group B |
| Single, 600 kcal mealSubjects will receive a single, 600 kcal meal during meal study | Other | Liquid Meal Study Group A, Solid Meal Study Group A |
| Multiple, 200 kcal mealsSubjects will receive three, 200 kcal meals, during meal study | Other | Liquid Meal Study Group B, Solid Meal Study Group B |
Primary outcome
Difference in GLP-1 levels before and after gastric bypass surgery
Time frame: 12-15 months
Investigators will assess GLP-1 levels in subjects pre and post-GBP
Difference in glucose levels before and after gastric bypass surgery
Time frame: 12-15 months
Investigators will assess glucose in subjects pre and post-GBP
Difference in insulin levels before and after gastric bypass surgery
Time frame: 12-15 months
Investigators will assess insulin levels in subjects pre and post-GBP
3 secondary outcomes
Difference in GLP-1 levels in solid vs liquid meals
Time frame: 12-15 months
Difference in glucose levels in solid vs liquid meals
Time frame: 12-15 months
Difference in insulin levels in solid vs liquid meals
Time frame: 12-15 months
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 1 Feb 2017.
- Individual participant dataSharing planned: No
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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
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solid Meal, Liquid Meal and Acetaminophen in people with Morbid Obesity, run by Columbia University 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 0 inclusion and 9 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 1 Feb 2017. 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?
Difference in GLP-1 levels before and after gastric bypass surgery (time frame: 12-15 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 1 Feb 2017.