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DIT After RYGB - A Prospective Study (DIT RYGB)

Primary Purpose

Obesity, Morbid Obesity, Bariatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
A standard mixed Meal
Sponsored by
Silvia Leite Faria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring Diet-induced Thermogenesis;, Respiratory Quotient;, Roux-en-Y Gastric Bypass;, Energy Expenditure.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pre-op: Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with associated co-morbidities. Age > 18 years
  • Post-op: Patients who underwent surgery ≥ 12 months by the Head Surgeon of the Gastrocirurgia de Brasilia Clinic;

Exclusion Criteria:

  • Patients aged > 65 years. Severe heart and/or respiratory problems; Pregnant women.

Sites / Locations

  • Gastrocirurgia de Brasilia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A standard mixed Meal

Arm Description

The standard mixed meal was composed of a chicken salad sandwich and 200ml of coconut water, totalling 260 kcal, distributed among carbohydrates (62%), proteins (12%) and lipids (26%).

Outcomes

Primary Outcome Measures

Post-op DIT increase
A post-op increase in DIT is expected to be greater than in pre-op period and may be a positive predictor for weight loss during the post-op phase.

Secondary Outcome Measures

Post-op RQ increase
A postprandial increase in RQ greater than that in the pre-op phase is expected showing improvement in carbohydrate metabolism after RYGB.

Full Information

First Posted
December 14, 2012
Last Updated
December 27, 2012
Sponsor
Silvia Leite Faria
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1. Study Identification

Unique Protocol Identification Number
NCT01759667
Brief Title
DIT After RYGB - A Prospective Study
Acronym
DIT RYGB
Official Title
Diet-induced Thermogenesis After Roux-en-Y Gastric Bypass - A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Silvia Leite Faria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese patients. This loss is a result of several factors that go beyond the simple anatomical abnormality of the gastrointestinal tract and may be the product of post-op energy expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are important components of energy expenditure and possible changes in them can perform an important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients, which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The objective of this study is to perform a prospective analysis of these same variables (RQ and DIT), evaluating them in the same patients, when pre and postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity, Bariatric Surgery
Keywords
Diet-induced Thermogenesis;, Respiratory Quotient;, Roux-en-Y Gastric Bypass;, Energy Expenditure.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A standard mixed Meal
Arm Type
Experimental
Arm Description
The standard mixed meal was composed of a chicken salad sandwich and 200ml of coconut water, totalling 260 kcal, distributed among carbohydrates (62%), proteins (12%) and lipids (26%).
Intervention Type
Other
Intervention Name(s)
A standard mixed Meal
Intervention Description
All patients underwent an indirect calorimetry test, after a 12-h period of fasting from food and water, avoiding intake of alcohol or coffee, and avoiding physical exercise and cigarettes the day before the examination. To examine possible changes in the thermogenic effect of food, patients received a standard mixed meal (200 ml coconut water and a chicken salad sandwich using whole wheat bread). They then repeated the test 20 min and 60 min after eating to obtain a reading of the metabolic rate by considering DIT and the RQ in the postprandial period.
Primary Outcome Measure Information:
Title
Post-op DIT increase
Description
A post-op increase in DIT is expected to be greater than in pre-op period and may be a positive predictor for weight loss during the post-op phase.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Post-op RQ increase
Description
A postprandial increase in RQ greater than that in the pre-op phase is expected showing improvement in carbohydrate metabolism after RYGB.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pre-op: Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with associated co-morbidities. Age > 18 years Post-op: Patients who underwent surgery ≥ 12 months by the Head Surgeon of the Gastrocirurgia de Brasilia Clinic; Exclusion Criteria: Patients aged > 65 years. Severe heart and/or respiratory problems; Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia L Faria, M.Science
Organizational Affiliation
Gastrocirurgia de Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrocirurgia de Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70390-108
Country
Brazil

12. IPD Sharing Statement

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DIT After RYGB - A Prospective Study

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