Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

Influence of the Sleep and Chronotype Pattern in Metabolic, Anthropometric and Biochemical Responses in Patients Submitted to Bariatric Surgery

The present study has a prospective, longitudinal and observational character, will be performed with patients attending a private clinic specialized in the treatment of obesity and bariatric surgery. Patients to be analyzed should have a medical indication for bariatric surgery.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate

Detailed Description

The patients will be selected for ten months and will be monitored for 12 months there are preoperative period, 3 months, 6 months and 12 months after surgery. Anthropometrical evaluation, biochemistry, polysomnography and sleep questionnaire (Epworth and Psqi) and midpoint sleep questionnaires will be performed to classify the chronotype for sleep pattern evaluation.

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

• Study Contact: Name: Cibele A Crispim, PhD; Phone Number: 55343218-2084; Email: cibelecrispim@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38.405-320
      • Cibele Aparecida Crispim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Bariatric Surgery patients

Description

Inclusion Criteria:

• Agree to participate in the study and sign the Informed Consent Form (EHIC)
• Patients submitted to By-pass or Sleeve bariatric surgery or Endossleve
• Patients with BMI above 35 kg / m².
• Over the age of 18 and up to 60 years.

Exclusion Criteria:

• Failure to provide the information necessary for the development of the study.
• Patients undergo revisional surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bariatric Surgery patients; Patients attending a private clinic specialized in the treatment of obesity and bariatric surgery. Patients to be analyzed should have a medical indication for bariatric surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in Kg	Anthropometric assessment will be evaluated using weight (kg).	Baseline, 3 and 6 months
BMI in Kg/m²	Anthropometric assessment will be evaluated using BMI (kg/m²).	Baseline, 3 and 6 months
Waist Circumference in Centimeters (cm)	Anthropometric assessment will be evaluated using waist circumference (cm)	Baseline, 3 and 6 months
Hip Circumference in Centimeters (cm)	Anthropometric assessment will be evaluated using hip circumference (cm)	Baseline, 3 and 6 months
Neck Circumference in Centimeters (cm)	Anthropometric assessment will be evaluated using neck circumference (cm)	Baseline, 3 and 6 months
Metabolic Parameters - Fasting Glucose (mg/dl)	Metabolic parameters will be evaluated using fasting glucose (mg/dl)	Baseline and 6 months
Metabolic Parameters - Insulin (mg/dl)	Metabolic parameters will be evaluated using insulin (mg/dl)	Baseline and 6 months
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)	Values of metabolic parameters will be evaluated using Homeostasis model assessment for beta-cell function (HOMA - IR) according to the standard assessment measurement in mg/dl. Higher values reflect worse insulin resistance	Baseline and 6 months
Metabolic Parameters - Cholesterol (mg/dl)	Metabolic parameters will be evaluated using Cholesterol (mg/dl)	Baseline and 6 months
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)	Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)	Baseline and 6 months
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)	Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)	Baseline and 6 months
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)	Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)	Baseline and 6 months
Metabolic Parameters - Triglycerides (mg/dl)	Metabolic parameters will be evaluated using Triglycerides (mg/dl)	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Consumption - Calories (Grams/Day)	The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).	Baseline, 3 and 6 months
Food Consumption - Carbohydrate (Grams/Day)	The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).	Baseline, 3 and 6 months
Food Consumption - Total Fat (Grams/Day)	The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).	Baseline, 3 and 6 months
Food Consumption - Polyunsaturated Fat (Grams/Day)	The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).	Baseline, 3 and 6 months
Food Consumption - Monounsaturated Fat (Grams/Day)	The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Cibele A Crispim, PhD, Federal University of Uberlandia

Publications and helpful links

General Publications

• Carvalho AC, Mota MC, Marot LP, Mattar LA, de Sousa JAG, Araujo ACT, da Costa Assis CT, Crispim CA. Circadian Misalignment Is Negatively Associated with the Anthropometric, Metabolic and Food Intake Outcomes of Bariatric Patients 6 Months After Surgery. Obes Surg. 2021 Jan;31(1):159-169. doi: 10.1007/s11695-020-04873-x. Epub 2020 Jul 29.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Bariatric Surgery; Chronotype
• Other Study ID Numbers: CEP UFU 2459483/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No