DIT After RYGB - A Prospective Study

NCT ID: NCT01759667

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-10-31

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.

Conditions

Obesity; Morbid Obesity; Bariatric Surgery

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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%).

Group Type: EXPERIMENTAL

A standard mixed Meal

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Silvia Leite Faria

OTHER

Sponsor Role: lead

Responsible Party

Silvia Leite Faria

Nutritionist, Master of Science in Human Nutrition

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Silvia L Faria, M.Science

Role: PRINCIPAL_INVESTIGATOR

Gastrocirurgia de Brasilia

Locations

Gastrocirurgia de Brasilia

Brasília, Federal District, Brazil

Countries

Brazil

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id