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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01938469
Other study ID # 09-117
Secondary ID
Status Completed
Phase N/A
First received August 21, 2013
Last updated December 28, 2016
Start date September 2010
Est. completion date July 2014

Study information

Verified date December 2016
Source St. Luke's-Roosevelt Hospital Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited Stated: Federal Government
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

- Severely obese patients undergoing gastric bypass surgery (GBP)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Liquid Meal

Solid Meal


Locations

Country Name City State
United States St. Lukes- Roosevelt Hospital- New York Obesity Research Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
St. Luke's-Roosevelt Hospital Center National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals. 1 month before GBP Surgery, and 12-15 months post surgery No
Primary Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals. 1 month before GBP surgery, and 12-15 months post surgery No
Primary Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals. 1 month before GBP surgery, 12-15 months post surgery No
Primary Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals. 1 month before GBP , 12-15 months post GBP No
Primary Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals. 1 month before GBP, 12-15 months post GBP No
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