DIT After RYGB - A Prospective Study

Not Applicable

Completed

• Conditions: Obesity; Morbid Obesity; Bariatric Surgery
• Interventions: Other: A standard mixed Meal

• Registration Number: NCT01759667
• Lead Sponsor: Silvia Leite Faria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-27
• Last Update Submitted: 2012-12-27
• Study First Posted: 2013-01-03
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A standard mixed Meal	A standard mixed Meal	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%).

Primary Outcome Measures

Name	Time	Method
Post-op DIT increase	2 months	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

Name	Time	Method
Post-op RQ increase	2 months	A postprandial increase in RQ greater than that in the pre-op phase is expected showing improvement in carbohydrate metabolism after RYGB.

Trial Locations

Locations (1)

Gastrocirurgia de Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil