Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

Completed

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT03485352
• Lead Sponsor: Federal University of Uberlandia

Brief Summary

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.

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 Timeline

• Study Start: 2017-06-05
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-02
• Primary Completion: 2018-04-30
• Study Completion: 2019-04-30
• Results First Submitted: 2020-10-04
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight in Kg	Baseline, 3 and 6 months	Anthropometric assessment will be evaluated using weight (kg).
Waist Circumference in Centimeters (cm)	Baseline, 3 and 6 months	Anthropometric assessment will be evaluated using waist circumference (cm)
BMI in Kg/m²	Baseline, 3 and 6 months	Anthropometric assessment will be evaluated using BMI (kg/m²).
Metabolic Parameters - Insulin (mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using insulin (mg/dl)
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)	Baseline and 6 months	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
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)
Metabolic Parameters - Triglycerides (mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using Triglycerides (mg/dl)
Hip Circumference in Centimeters (cm)	Baseline, 3 and 6 months	Anthropometric assessment will be evaluated using hip circumference (cm)
Metabolic Parameters - Cholesterol (mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using Cholesterol (mg/dl)
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)
Neck Circumference in Centimeters (cm)	Baseline, 3 and 6 months	Anthropometric assessment will be evaluated using neck circumference (cm)
Metabolic Parameters - Fasting Glucose (mg/dl)	Baseline and 6 months	Metabolic parameters will be evaluated using fasting glucose (mg/dl)

Secondary Outcome Measures

Name	Time	Method
Food Consumption - Polyunsaturated Fat (Grams/Day)	Baseline, 3 and 6 months	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).
Food Consumption - Calories (Grams/Day)	Baseline, 3 and 6 months	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).
Food Consumption - Carbohydrate (Grams/Day)	Baseline, 3 and 6 months	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).
Food Consumption - Monounsaturated Fat (Grams/Day)	Baseline, 3 and 6 months	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).
Food Consumption - Total Fat (Grams/Day)	Baseline, 3 and 6 months	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).

Trial Locations

Locations (1)

Cibele Aparecida Crispim; 🇧🇷 Uberlândia, Minas Gerais, Brazil