Clinical trial NCT03485352: Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery
Official title: Influence of the Sleep and Chronotype Pattern in Metabolic, Anthropometric and Biochemical Responses in Patients Submitted to Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric Surgery
Sleep
Chronotype
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bariatric Surgery patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight in Kg
timeFrame: Baseline, 3 and 6 months
measure: BMI in Kg/m²
timeFrame: Baseline, 3 and 6 months
measure: Waist Circumference in Centimeters (cm)
timeFrame: Baseline, 3 and 6 months
measure: Hip Circumference in Centimeters (cm)
timeFrame: Baseline, 3 and 6 months
measure: Neck Circumference in Centimeters (cm)
timeFrame: Baseline, 3 and 6 months
measure: Metabolic Parameters - Fasting Glucose (mg/dl)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - Insulin (mg/dl)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - Cholesterol (mg/dl)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)
timeFrame: Baseline and 6 months
measure: Metabolic Parameters - Triglycerides (mg/dl)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Food Consumption - Calories (Grams/Day)
timeFrame: Baseline, 3 and 6 months
measure: Food Consumption - Carbohydrate (Grams/Day)
timeFrame: Baseline, 3 and 6 months
measure: Food Consumption - Total Fat (Grams/Day)
timeFrame: Baseline, 3 and 6 months
measure: Food Consumption - Polyunsaturated Fat (Grams/Day)
timeFrame: Baseline, 3 and 6 months
measure: Food Consumption - Monounsaturated Fat (Grams/Day)
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Cibele Aparecida Crispim
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Cibele A Crispim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.