NCT01938469

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

3.8 years

First QC Date

August 21, 2013

Last Update Submit

December 28, 2016

Conditions

Gastric Bypass SurgeryObesity

Keywords

BariatricGastric BypassGastric Banding,Incretinsglucagon-like peptide-1(GLP-1)gastric inhibitory peptide (GIP)

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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).

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).

Other: Liquid Meal

Interventions

Liquid MealOTHER
Liquid Meal
Solid MealOTHER
Solid Meal

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Severely obese patients undergoing gastric bypass surgery (GBP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Lukes- Roosevelt Hospital- New York Obesity Research Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Blandine Laferrere, MD

    New York Obesity Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 10, 2013

Study Start

September 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations

US(1)