NCT02422212

Brief Summary

Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78 million American adults are obese. Bariatric surgery can provide for a sustained long-term weight loss and the metabolic change caused by the surgery seems to be the main cause of this loss. Cross-sectional, prospective and experimental studies, carried out during the post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an increase of over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a specific component of energy expenditure) when compared with obese patients. However, despite this metabolic improvement, 20-50% of the patients can suffer weight regain about 2 years after surgery. So one question whether such metabolic benefits remain active following post-operative weight regain, or if the disappearance or decrease of these metabolic benefits may be seen as causes of this weight regain. Objective:To evaluate whether there are DIT differences between patients who maintained weight loss and those who regained weight in the late postoperative (postop) period of RYGBP and those who continue with preoperative (preop) obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

3 active sites

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

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

April 9, 2015

Last Update Submit

April 22, 2015

Conditions

ObesityBariatric Surgery CandidateProtein-energy; Imbalance

Keywords

metabolismDiet Induced Thermogenesisweight regainenergy expenditurebariatric

Outcome Measures

Primary Outcomes (1)

  • Measurement of Diet Induced thermogenesis

    The three groups were given an indirect calorimetry examination (GERATHERM RESPIRATORY®) to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. To assure proper measurement of RER, the patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal of 270 kcal, which was 62% carbohydrate, 12% protein and 26% lipid. Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180. In this way, a PP-time period of 3 hours was accompanied. The DIT was calculated for each time interval, based on the following equation: DIT = Metabolic rate (MR) PP time interval as X - RMR.

    180 minuts

Study Arms (3)

healthy weight group

ACTIVE COMPARATOR

Postop RYGBP patients who underwent surgery at least 2 years previously and have healthy weight (at least 50% loss of excess weight) (HW group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid)

Other: patients eat a mixed solid meal

Obese group

OTHER

Clinically severe obese patients (Body Mass Index greater than 40 kg/m2, without co-morbidities and greater than 35 kg/m2 with co-morbidities) (OB group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid)

Other: patients eat a mixed solid meal

weight regain group

ACTIVE COMPARATOR

Patients who suffered weight regain after RYGBP (at least 10% above the minimum weight after surgery and less than 50% loss of preop excess weight) (WR group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid)

Other: patients eat a mixed solid meal

Interventions

patients eat a mixed solid mealOTHER

The three groups were given an indirect calorimetry examination to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. The patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal (270 kcal, with 62% carbohydrate, 12% protein and 26% lipid). Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180.The DIT was calculated for each time interval.

Obese grouphealthy weight groupweight regain group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bariatric patients (those who had done Roux-en-Y Gastric Bypass) who have more than 2 years of surgery with healthy weight and also those with weight regain
  • Obese population in pre operative phase of bariatric surgery

You may not qualify if:

  • Patients if male sex,
  • pregnant or breastfeeding patients,
  • patients with more than 5 years of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gastrocirurgia de Brasilia

Brasília, Federal District, 70390-108, Brazil

Location

Gastrocirurgia de Brasilia

Brasília, Federal District, 70390108, Brazil

Location

Gastrocirurgia

Brasília, Federal District, 70390108, Brazil

Location

Related Publications (3)

  • Faria SL, Faria OP, Cardeal Mde A, Ito MK, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass surgery: a prospective study. Surg Obes Relat Dis. 2014 Jan-Feb;10(1):138-43. doi: 10.1016/j.soard.2013.09.020. Epub 2013 Oct 10.

    PMID: 24507080BACKGROUND

  • Faria SL, Faria OP, Cardeal Mde A, de Gouvea HR, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):797-802. doi: 10.1016/j.soard.2012.06.008. Epub 2012 Jul 23.

    PMID: 22884301BACKGROUND

  • Stylopoulos N, Hoppin AG, Kaplan LM. Roux-en-Y gastric bypass enhances energy expenditure and extends lifespan in diet-induced obese rats. Obesity (Silver Spring). 2009 Oct;17(10):1839-47. doi: 10.1038/oby.2009.207. Epub 2009 Jun 25.

    PMID: 19556976BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph D

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 21, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

BR(3)