Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485352
• Other study ID #: CEP UFU 2459483/2017
• Status: Completed
• Start date: June 5, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2023
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2018
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Locations

Country	Name	City	State
Brazil	Cibele Aparecida Crispim	Uberlândia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in Kg	Anthropometric assessment will be evaluated using weight (kg).	Baseline, 3 and 6 months
Primary	BMI in Kg/m²	Anthropometric assessment will be evaluated using BMI (kg/m²).	Baseline, 3 and 6 months
Primary	Waist Circumference in Centimeters (cm)	Anthropometric assessment will be evaluated using waist circumference (cm)	Baseline, 3 and 6 months
Primary	Hip Circumference in Centimeters (cm)	Anthropometric assessment will be evaluated using hip circumference (cm)	Baseline, 3 and 6 months
Primary	Neck Circumference in Centimeters (cm)	Anthropometric assessment will be evaluated using neck circumference (cm)	Baseline, 3 and 6 months
Primary	Metabolic Parameters - Fasting Glucose (mg/dl)	Metabolic parameters will be evaluated using fasting glucose (mg/dl)	Baseline and 6 months
Primary	Metabolic Parameters - Insulin (mg/dl)	Metabolic parameters will be evaluated using insulin (mg/dl)	Baseline and 6 months
Primary	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
Primary	Metabolic Parameters - Cholesterol (mg/dl)	Metabolic parameters will be evaluated using Cholesterol (mg/dl)	Baseline and 6 months
Primary	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
Primary	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
Primary	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
Primary	Metabolic Parameters - Triglycerides (mg/dl)	Metabolic parameters will be evaluated using Triglycerides (mg/dl)	Baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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