Clinical trial NCT01938469: Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Official title: Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Bypass Surgery
Obesity
Keywords: Bariatric
Gastric Bypass
Gastric Banding,
Incretins
glucagon-like peptide-1(GLP-1)
gastric inhibitory peptide (GIP)
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-09-10
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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.

Eligibility criteria: Inclusion Criteria:

* Severely obese patients undergoing gastric bypass surgery (GBP)

Primary outcomes:
measure: Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
timeFrame: 1 month before GBP Surgery, and 12-15 months post surgery
measure: Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
timeFrame: 1 month before GBP surgery, and 12-15 months post surgery
measure: Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
timeFrame: 1 month before GBP surgery, 12-15 months post surgery
measure: Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
timeFrame: 1 month before GBP , 12-15 months post GBP
measure: Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
timeFrame: 1 month before GBP, 12-15 months post GBP
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Lukes- Roosevelt Hospital- New York Obesity Research Center
state: New York
Study officials:
affiliation: New York Obesity Nutrition Research Center
name: Blandine Laferrere, MD
role: PRINCIPAL_INVESTIGATOR
References: