Influence of the Sleep and Chronotype Pattern in Metabolic, Anthropometric and Biochemical Responses in Patients Submitted to Bariatric Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bariatric Surgery Candidate
- Sponsor
- Federal University of Uberlandia
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Weight in Kg
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Cibele Aparecida Crispim
Principal Investigator
Federal University of Uberlandia
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
Outcomes
Primary Outcomes
Weight in Kg
Time Frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using weight (kg).
Waist Circumference in Centimeters (cm)
Time Frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using waist circumference (cm)
BMI in Kg/m²
Time Frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using BMI (kg/m²).
Metabolic Parameters - Insulin (mg/dl)
Time Frame: Baseline and 6 months
Metabolic parameters will be evaluated using insulin (mg/dl)
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)
Time Frame: 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)
Time Frame: Baseline and 6 months
Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)
Metabolic Parameters - Triglycerides (mg/dl)
Time Frame: Baseline and 6 months
Metabolic parameters will be evaluated using Triglycerides (mg/dl)
Hip Circumference in Centimeters (cm)
Time Frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using hip circumference (cm)
Metabolic Parameters - Cholesterol (mg/dl)
Time Frame: Baseline and 6 months
Metabolic parameters will be evaluated using Cholesterol (mg/dl)
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)
Time Frame: 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)
Time Frame: Baseline and 6 months
Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)
Neck Circumference in Centimeters (cm)
Time Frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using neck circumference (cm)
Metabolic Parameters - Fasting Glucose (mg/dl)
Time Frame: Baseline and 6 months
Metabolic parameters will be evaluated using fasting glucose (mg/dl)
Secondary Outcomes
- Food Consumption - Polyunsaturated Fat (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Calories (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Carbohydrate (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Monounsaturated Fat (Grams/Day)(Baseline, 3 and 6 months)
- Food Consumption - Total Fat (Grams/Day)(Baseline, 3 and 6 months)