Resting Metabolic Rate is a Predictor of Weight Regain?

NCT04118582 | Completed

• 1 other identifier: 00984812.5.0000.0068
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

he increasing prevalence of obesity in developed countries has also reached Brazil in the last two decades. Conventional treatments are not efficient to sustained weight loss and in some cases, weight reduction in individuals refractory to these methods. Bariatric surgery has been considered as the most efficient long-term treatment. However, numerous studies have reported weight regain in approximately 20% of patients, from the second year of surgery. The objective of this study is to analyze the changes in resting metabolic rate and body composition before, 6 and 36 months after weight loss and its relation to late weight regain. 48 adults of both sexes, above 18 years, will undergo bypass performed the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP. Patients over 60 years, undergoing revision surgery and other surgical techniques will be excluded. The body weight (kg) will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Excess weight (kg): difference in preoperative weight versus ideal weight considered for weight for BMI 25kg/m2. Weight loss (kg): pre-surgery weight difference in relation to the lowest weight reached after 18 months. Percentage of excess of weight loss is difference of weight loss in relation to overweight, used as an indicator of success of surgery. Fat mass (%, kg) and fat-free mass (%, kg) will be obtained by electrical bioimpedance 230, 2.0. For resting metabolic rate, the values of VO2 and VCO2 will be collected by indirect calorimetry using Ultima CPX metabolic analyzer. The daily energy expenditure (kcal/day) will be calculated by the Weir equation. keywords: obesity, resting metabolic rate, body composition analysis, bariatric surgery.

Conditions

Severe Obesity

Keywords

severe obesity; resting metabolic rate; indirect calorimetry; body composition; electrical bioimpedance analisys

Outcome Measures

Primary Outcomes (3)

• Changes in resting metabolic rate

  This will be evaluated by indirect calorimetry before and after bariatric surgery: kcal per day and per kilogram fat free mass.

  Before, 6 months and 36 months after bariatric surgery

• Late weight regain

  This will be evaluated considering the lowest weight (in kilos) reached after 18 months of bariatric surgery

  18 months of bariatric surgery

• Changes in body composition

  This will be evaluated fat mass (kg, %) and fat-free mass (kg,%) by electrical bioimpedance before and after 6 and 36 months of bariatric surgery.

  Before, 6 months and 36 months after bariatric surgery

Study Arms (1)

Prospective analisys

Bioimpedance The BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance (BIA) 230, 2.0, (Biospace Seoul, Korea). Those evaluated will be standing and positioned on the platform electrodes, barefoot and with their arms extended with their hands on the two supports (electrodes). Evaluation of RMR For the evaluation of the RMR, the values of VO2 and VCO2 will be collected by the indirect calorimetry (IC) method using the Ultima CPX metabolic analyzer (MedGraphics, USA), calibrated with each test.

Other: Body composition and resting metabolic rate analisys

Interventions

Body composition and resting metabolic rate analisys OTHER

Prospective analisys

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample consists of 48 adults, both sexes, BMI \> 40 kg/m² \< 60 kg/m², selected at the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology at the Clinical Hospital of the Medical School of the University of Sao Paulo (HCFMUSP).

You may qualify if:

• Both sexes,
• Above 18 to 60 years

You may not qualify if:

• Adult patients over 60 years old,
• patients undergoing revision surgery and other surgical techniques will be excluded.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403900, Brazil

Location

Related Publications (4)

• Santo MA, Riccioppo D, Pajecki D, Kawamoto F, de Cleva R, Antonangelo L, Marcal L, Cecconello I. Weight Regain After Gastric Bypass: Influence of Gut Hormones. Obes Surg. 2016 May;26(5):919-25. doi: 10.1007/s11695-015-1908-z.

  PMID: 26450709 BACKGROUND

• Browning MG, Franco RL, Cyrus JC, Celi F, Evans RK. Changes in Resting Energy Expenditure in Relation to Body Weight and Composition Following Gastric Restriction: A Systematic Review. Obes Surg. 2016 Jul;26(7):1607-15. doi: 10.1007/s11695-016-2184-2.

  PMID: 27103027 BACKGROUND

• Faria SL, Faria OP, Cardeal Mde A, de Gouvea HR, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):797-802. doi: 10.1016/j.soard.2012.06.008. Epub 2012 Jul 23.

  PMID: 22884301 BACKGROUND

• Flancbaum L, Verducci JS, Choban PS. Changes in measured resting energy expenditure after Roux-en-Y gastric bypass for clinically severe obesity are not related to bypass limb-length. Obes Surg. 1998 Aug;8(4):437-43. doi: 10.1381/096089298765554331.

  PMID: 9731680 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Body Composition

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Study Officials

• Roberto de Cleva, MD PhD

  Clinical Hospital of University of Sao Paulo Medical School

  STUDY CHAIR

• Lilian Cardia, MsC

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: October 8, 2019
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 31, 2018
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

BR (1)