Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

NCT ID: NCT03485352

Last Updated: 2024-04-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-05

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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Cibele Aparecida Crispim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cibele A Crispim, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Cibele Aparecida Crispim

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 32728839 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CEP UFU 2459483/2017

Identifier Type: -

Identifier Source: org_study_id

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