NCT01396460

Brief Summary

Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period. Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients. The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

July 15, 2011

Last Update Submit

September 7, 2012

Conditions

Keywords

respiratory quotientfat oxidationmorbid obesitybariatricBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Diet Induced Thermogenesis

    To examine the possible changes in the thermic effect of food, the patients received a standard meal. They then repeated the test 20 minutes after eating to obtain a reading of the metabolic rate by considering the DIT and RQ in the postprandial period. DIT was calculated as the difference between post prandial metabolic rate and RMR.

    20min after standard meal

Study Arms (2)

bariatric patients

Bariatric post operative patients were compared with morbid obese population

Other: breakfast (a chicken sandwich with juice)

control group

morbid obese population

Interventions

patients received a breakfast after de initial measurement

bariatric patients

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bariatric post operative population

You may qualify if:

  • With more than 1 year after surgery
  • Consent given to participate

You may not qualify if:

  • Pregnant women
  • Malnourished patients (anemia)
  • Tiroid disorders without treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrocirurgia de Brasilia

Brasília, Federal District, 70390108, Brazil

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Breakfast

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Silvia Leite Faria , MSc, RD

Study Record Dates

First Submitted

July 15, 2011

First Posted

July 18, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations