DIT After RYGB - A Prospective Study

Obesity Clinical Trial

— DIT RYGB  

Official title:

Diet-induced Thermogenesis After Roux-en-Y Gastric Bypass - A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759667
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: December 27, 2012
• Start date: August 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Gastrocirurgia, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bariatric Surgery
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Other:
• A standard mixed Meal
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.

Locations

Country	Name	City	State
Brazil	Gastrocirurgia de Brasilia	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Silvia Leite Faria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months	No
Secondary	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.	2 months	No