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Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery

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ClinicalTrials.gov Identifier: NCT01938469
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Brief 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).

Condition or disease Intervention/treatment Phase
Gastric Bypass Surgery Obesity Other: Liquid Meal Other: Solid Meal Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Study Start Date : September 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Solid Meal
Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).
Other: Solid Meal
Liquid Meal
Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).
Other: Liquid Meal



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severely obese patients undergoing gastric bypass surgery (GBP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938469


Locations
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United States, New York
St. Lukes- Roosevelt Hospital- New York Obesity Research Center
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Blandine Laferrere, MD New York Obesity Nutrition Research Center

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Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01938469     History of Changes
Other Study ID Numbers: 09-117
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Bariatric
Gastric Bypass
Gastric Banding,
Incretins
glucagon-like peptide-1(GLP-1)
gastric inhibitory peptide (GIP)

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms