DIT After RYGB - A Prospective Study

NCT01759667 | Completed

• 1 other identifier: 002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Diet-induced Thermogenesis;; Respiratory Quotient;; Roux-en-Y Gastric Bypass;; Energy Expenditure.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Post-op RQ increase

  2 months

Study Arms (1)

A standard mixed Meal

EXPERIMENTAL

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%).

Other: A standard mixed Meal

Interventions

A standard mixed Meal 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.

A standard mixed Meal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Silvia Leite Faria: lead

Study Sites (1)

Gastrocirurgia de Brasilia

Brasília, Federal District, 70390-108, Brazil

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia L Faria, M.Science

  Gastrocirurgia de Brasilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nutritionist, Master of Science in Human Nutrition

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: January 3, 2013
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

BR (1)