Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

NCT03485352 | Completed Results DMC

• 1 other identifier: CEP UFU 2459483/2017
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric Surgery; Sleep; Chronotype

Outcome Measures

Primary Outcomes (13)

• Weight in Kg

  Anthropometric assessment will be evaluated using weight (kg).

  Baseline, 3 and 6 months

• BMI in Kg/m²

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

  Baseline, 3 and 6 months

• Waist Circumference in Centimeters (cm)

  Anthropometric assessment will be evaluated using waist circumference (cm)

  Baseline, 3 and 6 months

• Hip Circumference in Centimeters (cm)

  Anthropometric assessment will be evaluated using hip circumference (cm)

  Baseline, 3 and 6 months

• Neck Circumference in Centimeters (cm)

  Anthropometric assessment will be evaluated using neck circumference (cm)

  Baseline, 3 and 6 months

• Metabolic Parameters - Fasting Glucose (mg/dl)

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

  Baseline and 6 months

• Metabolic Parameters - Insulin (mg/dl)

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

  Baseline and 6 months

• 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

• Metabolic Parameters - Cholesterol (mg/dl)

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

  Baseline and 6 months

• 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

• 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

• 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

• Metabolic Parameters - Triglycerides (mg/dl)

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

  Baseline and 6 months

Secondary Outcomes (5)

• Food Consumption - Calories (Grams/Day)

  Baseline, 3 and 6 months

• Food Consumption - Carbohydrate (Grams/Day)

  Baseline, 3 and 6 months

• Food Consumption - Total Fat (Grams/Day)

  Baseline, 3 and 6 months

• Food Consumption - Polyunsaturated Fat (Grams/Day)

  Baseline, 3 and 6 months

• Food Consumption - Monounsaturated Fat (Grams/Day)

  Baseline, 3 and 6 months

Study Arms (1)

Bariatric Surgery patients

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Bariatric Surgery patients

You may qualify if:

• 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.

You may not qualify if:

• Failure to provide the information necessary for the development of the study.
• Patients undergo revisional surgery

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Cibele Aparecida Crispim

Uberlândia, Minas Gerais, 38.405-320, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32728839 DERIVED

Limitations and Caveats

Use of questionnaires, which, although valid and widely used in others research, are subjective and dependent on the participants' memory. The participants underwent only two different surgical techniques in a private service.

Results Point of Contact

• Title: Mrs Cibele Crispim
• Organization: Federal University of Uberlandia

cibelecrispim@gmail.com

55 34 3218-2084

Study Officials

• Cibele A Crispim, PhD

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: April 2, 2018
• Study Start: June 5, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2019
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)