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Completed

NCT Number: NCT01759667

DIT After RYGB - A Prospective Study

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.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrocirurgia de Brasilia

Brasília, Federal District, 70390-108, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Post-op DIT increase

    Time frame: 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 outcomes

  1. Post-op RQ increase

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Silvia Leite Faria

Other

Registry information

Official study title

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

Acronym: DIT RYGB

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 3, 2013
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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