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Completed

NCT Number: NCT03485352

Influence of the Sleep Pattern 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.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cibele Aparecida Crispim

Uberlândia, Minas Gerais, 38.405-320, Brazil

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Weight in Kg

    Time frame: Baseline, 3 and 6 months

    Anthropometric assessment will be evaluated using weight (kg).

  2. BMI in Kg/m²

    Time frame: Baseline, 3 and 6 months

    Anthropometric assessment will be evaluated using BMI (kg/m²).

  3. Waist Circumference in Centimeters (cm)

    Time frame: Baseline, 3 and 6 months

    Anthropometric assessment will be evaluated using waist circumference (cm)

  4. Hip Circumference in Centimeters (cm)

    Time frame: Baseline, 3 and 6 months

    Anthropometric assessment will be evaluated using hip circumference (cm)

  5. Neck Circumference in Centimeters (cm)

    Time frame: Baseline, 3 and 6 months

    Anthropometric assessment will be evaluated using neck circumference (cm)

  6. Metabolic Parameters - Fasting Glucose (mg/dl)

    Time frame: Baseline and 6 months

    Metabolic parameters will be evaluated using fasting glucose (mg/dl)

  7. Metabolic Parameters - Insulin (mg/dl)

    Time frame: Baseline and 6 months

    Metabolic parameters will be evaluated using insulin (mg/dl)

  8. 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

  9. Metabolic Parameters - Cholesterol (mg/dl)

    Time frame: Baseline and 6 months

    Metabolic parameters will be evaluated using Cholesterol (mg/dl)

  10. 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)

  11. 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)

  12. 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)

  13. Metabolic Parameters - Triglycerides (mg/dl)

    Time frame: Baseline and 6 months

    Metabolic parameters will be evaluated using Triglycerides (mg/dl)

Secondary outcomes

  1. Food Consumption - Calories (Grams/Day)

    Time frame: 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).

  2. Food Consumption - Carbohydrate (Grams/Day)

    Time frame: 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).

  3. Food Consumption - Total Fat (Grams/Day)

    Time frame: 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).

  4. Food Consumption - Polyunsaturated Fat (Grams/Day)

    Time frame: 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).

  5. Food Consumption - Monounsaturated Fat (Grams/Day)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 2, 2018
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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