Bariatric Surgery CandidateNCT03485352

Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

An observational study of Bariatric Surgery Candidate, run by Federal University of Uberlandia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Bariatric Surgery Candidate
How many people: 122 participants
Where: 1 siteBrazil
Study dates: 5 Jun 2017to 30 Apr 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Adult

Study population: Bariatric Surgery patients

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Cibele Aparecida Crispim
Uberlândia, Minas Gerais, 38.405-320

Other trials in Brazil

About this study

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

Read the 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.

Conditions: Bariatric Surgery Candidate
Keywords: Bariatric Surgery, Sleep, Chronotype

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03485352
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight in Kg
Anthropometric assessment will be evaluated using weight (kg).
Measured: Baseline, 3 and 6 months
BMI in Kg/m²
Anthropometric assessment will be evaluated using BMI (kg/m²).
Measured: Baseline, 3 and 6 months
Waist Circumference in Centimeters (cm)
Anthropometric assessment will be evaluated using waist circumference (cm)
Measured: Baseline, 3 and 6 months
Hip Circumference in Centimeters (cm)
Anthropometric assessment will be evaluated using hip circumference (cm)
Measured: Baseline, 3 and 6 months
Neck Circumference in Centimeters (cm)
Anthropometric assessment will be evaluated using neck circumference (cm)
Measured: Baseline, 3 and 6 months
Metabolic Parameters - Fasting Glucose (mg/dl)
Metabolic parameters will be evaluated using fasting glucose (mg/dl)
Measured: Baseline and 6 months
Metabolic Parameters - Insulin (mg/dl)
Metabolic parameters will be evaluated using insulin (mg/dl)
Measured: 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
Measured: Baseline and 6 months
Metabolic Parameters - Cholesterol (mg/dl)
Metabolic parameters will be evaluated using Cholesterol (mg/dl)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and 6 months
Metabolic Parameters - Triglycerides (mg/dl)
Metabolic parameters will be evaluated using Triglycerides (mg/dl)
Measured: Baseline and 6 months

Secondary outcomes (5)

Food Consumption - Calories (Grams/Day)
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).
Measured: Baseline, 3 and 6 months
Food Consumption - Carbohydrate (Grams/Day)
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).
Measured: Baseline, 3 and 6 months
Food Consumption - Total Fat (Grams/Day)
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).
Measured: Baseline, 3 and 6 months
Food Consumption - Polyunsaturated Fat (Grams/Day)
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).
Measured: Baseline, 3 and 6 months
Food Consumption - Monounsaturated Fat (Grams/Day)
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).
Measured: Baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 201730 Apr 2019

First posted2 Apr 2018
Study start5 Jun 2017
Primary completion30 Apr 2018
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03485352
Sponsor's protocol ID: CEP UFU 2459483/2017
Status last verified: Sep 2023
First submitted: 20 Feb 2018
Last updated: 1 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Carvalho AC, Marot LP, Mattar LA, de Sousa JAG, Araujo ACT, da Costa Assis CT, Mota MC, Crispim CA. Associations of subjective sleep patterns and social jet lag with weight loss and dietary intake in bariatric surgery patients: a 1-year follow-up study. Br J Nutr. 2025 Mar 14;133(5):711-720. doi: 10.1017/S0007114525000352. Epub 2025 Feb 24.
PubMed 39991887
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.
PubMed 32728839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bariatric Surgery Candidate trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of the Sleep and Chronotype Pattern in Metabolic, Anthropometric and Biochemical Responses in Patients Submitted to Bariatric Surgery
ClinicalTrials.gov ID: NCT03485352
Acronym / sponsor ID: CEP UFU 2459483/2017
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric Surgery, Sleep, Chronotype
Study type: Observational
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Federal University of UberlandiaUniversity, hospital or other
Study start: 5 Jun 2017 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 2 Apr 2018 (actual)
Results: Posted 1 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Age groups: Adult
Study population: Bariatric Surgery patients

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Weight in Kg
Time frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using weight (kg).
BMI in Kg/m²
Time frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using BMI (kg/m²).
Waist Circumference in Centimeters (cm)
Time frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using waist circumference (cm)
Hip Circumference in Centimeters (cm)
Time frame: Baseline, 3 and 6 months
Anthropometric assessment will be evaluated using hip circumference (cm)
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)
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 - Cholesterol (mg/dl)
Time frame: Baseline and 6 months
Metabolic parameters will be evaluated using Cholesterol (mg/dl)
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 - 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)
Metabolic Parameters - Triglycerides (mg/dl)
Time frame: Baseline and 6 months
Metabolic parameters will be evaluated using Triglycerides (mg/dl)

5 secondary outcomes

Food Consumption - Calories (Grams/Day)
Time frame: Baseline, 3 and 6 months
Food Consumption - Carbohydrate (Grams/Day)
Time frame: Baseline, 3 and 6 months
Food Consumption - Total Fat (Grams/Day)
Time frame: Baseline, 3 and 6 months
Food Consumption - Polyunsaturated Fat (Grams/Day)
Time frame: Baseline, 3 and 6 months
Food Consumption - Monounsaturated Fat (Grams/Day)
Time frame: Baseline, 3 and 6 months

Results and safety

Results posted to the registry on 1 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bariatric Surgery Patients	122	113

Primary outcome: Weight in Kg

Time frame: Baseline, 3 and 6 months. Mean (Standard Error). Unit: Kg

Measure	Small SJL n = 60	Large SJL n = 62
Baseline	111.4 (2.1)	116.4 (3.3)
3 months	89.7 (1.7)	93.5 (2.7)
6 months	77.5 (1.5)	84.2 (2.6)

Population analysed: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of weight in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Primary outcome: BMI in Kg/m²

Time frame: Baseline, 3 and 6 months. Mean (Standard Error). Unit: Kg/m²

Measure	Small SJL n = 60	Large SJL n = 62
Baseline	40.8 (0.4)	41.8 (0.8)
3 months	32.9 (0.4)	33.6 (0.7)
6 months	28.7 (0.4)	30.2 (0.7)

Population analysed: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of BMI in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Primary outcome: Waist Circumference in Centimeters (cm)

Time frame: Baseline, 3 and 6 months. Mean (Standard Error). Unit: Centimeters

Measure	Small SJL n = 60	Large SJL n = 62
Baseline	109.3 (1.4)	110.0 (1.7)
3 months	94.1 (1.2)	95.1 (1.4)
6 months	85.5 (1.1)	88.4 (1.4)

Population analysed: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of waist circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.

Primary outcome: Hip Circumference in Centimeters (cm)

Time frame: Baseline, 3 and 6 months. Mean (Standard Error). Unit: Centimeters

Measure	Small SJL n = 60	Large SJL n = 62
Baseline	128.9 (1.1)	131.4 (1.7)
3 months	114.9 (1.1)	117.8 (1.7)
6 months	105.8 (1.0)	109.9 (1.6)

Population analysed: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of hip circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 1 year and 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Small and Large Social Jetlag	0 of 122 (0%)	0 of 122 (0%)	0 of 122

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39991887Carvalho AC, Marot LP, Mattar LA, de Sousa JAG, Araujo ACT, da Costa Assis CT, Mota MC, Crispim CA. Associations of subjective sleep patterns and social jet lag with weight loss and dietary intake in bariatric surgery patients: a 1-year follow-up study. Br J Nutr. 2025 Mar 14;133(5):711-720. doi: 10.1017/S0007114525000352. Epub 2025 Feb 24.
Derived from this study: PubMed 32728839Carvalho 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cibele A Crispim, PhD principal investigator

Federal University of Uberlandia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery Candidate, run by Federal University of Uberlandia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight in Kg (time frame: Baseline, 3 and 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03485352, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.