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CompletedNCT03485352Updated Apr 1, 2024Results posted

Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery

An observational study in Bariatric Surgery Candidate, sponsored by Federal University of Uberlandia. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by Federal University of Uberlandia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bariatric Surgery Candidate

Keywords

  • Bariatric Surgery
  • Sleep
  • Chronotype
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Bariatric Surgery patients

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

Exclusion Criteria:

  • Failure to provide the information necessary for the development of the study.
  • Patients undergo revisional surgery
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Weight in Kg

    Anthropometric assessment will be evaluated using weight (kg).

    Time frame: Baseline, 3 and 6 months

  2. BMI in Kg/m²

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

    Time frame: Baseline, 3 and 6 months

  3. Waist Circumference in Centimeters (cm)

    Anthropometric assessment will be evaluated using waist circumference (cm)

    Time frame: Baseline, 3 and 6 months

  4. Hip Circumference in Centimeters (cm)

    Anthropometric assessment will be evaluated using hip circumference (cm)

    Time frame: Baseline, 3 and 6 months

  5. Neck Circumference in Centimeters (cm)

    Anthropometric assessment will be evaluated using neck circumference (cm)

    Time frame: Baseline, 3 and 6 months

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

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

    Time frame: Baseline and 6 months

  7. Metabolic Parameters - Insulin (mg/dl)

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

    Time frame: Baseline and 6 months

  8. 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

    Time frame: Baseline and 6 months

  9. Metabolic Parameters - Cholesterol (mg/dl)

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

    Time frame: Baseline and 6 months

  10. Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)

    Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)

    Time frame: Baseline and 6 months

  11. Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)

    Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)

    Time frame: Baseline and 6 months

  12. Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)

    Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)

    Time frame: Baseline and 6 months

  13. Metabolic Parameters - Triglycerides (mg/dl)

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

    Time frame: Baseline and 6 months

Secondary outcomes

  1. 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).

    Time frame: Baseline, 3 and 6 months

  2. 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).

    Time frame: Baseline, 3 and 6 months

  3. 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).

    Time frame: Baseline, 3 and 6 months

  4. 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).

    Time frame: Baseline, 3 and 6 months

  5. 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).

    Time frame: Baseline, 3 and 6 months

06

Results

Posted Apr 1, 2024
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.

Participant flow

Participant flow — Overall Study
MilestoneBariatric Surgery Patients
Started122
3 months117
Completed113
Not completed9
Withdrew: Lost to follow-up9

Outcome measures

PrimaryWeight in Kg

Anthropometric assessment will be evaluated using weight (kg).

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · Kg
Weight in Kg
KgSmall SJLLarge SJL
Baseline111.4 ± 2.1116.4 ± 3.3
3 months89.7 ± 1.793.5 ± 2.7
6 months77.5 ± 1.584.2 ± 2.6
PrimaryBMI in Kg/m²

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

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · Kg/m²
BMI in Kg/m²
Kg/m²Small SJLLarge SJL
Baseline40.8 ± 0.441.8 ± 0.8
3 months32.9 ± 0.433.6 ± 0.7
6 months28.7 ± 0.430.2 ± 0.7
PrimaryWaist Circumference in Centimeters (cm)

Anthropometric assessment will be evaluated using waist circumference (cm)

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · Centimeters
Waist Circumference in Centimeters (cm)
CentimetersSmall SJLLarge SJL
Baseline109.3 ± 1.4110.0 ± 1.7
3 months94.1 ± 1.295.1 ± 1.4
6 months85.5 ± 1.188.4 ± 1.4
PrimaryHip Circumference in Centimeters (cm)

Anthropometric assessment will be evaluated using hip circumference (cm)

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · Centimeters
Hip Circumference in Centimeters (cm)
CentimetersSmall SJLLarge SJL
Baseline128.9 ± 1.1131.4 ± 1.7
3 months114.9 ± 1.1117.8 ± 1.7
6 months105.8 ± 1.0109.9 ± 1.6
PrimaryNeck Circumference in Centimeters (cm)

Anthropometric assessment will be evaluated using neck circumference (cm)

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · Centimeters
Neck Circumference in Centimeters (cm)
CentimetersSmall SJLLarge SJL
Baseline39.2 ± 0.439.4 ± 0.5
3 months36.0 ± 0.436.3 ± 0.4
6 months34.4 ± 0.335.1 ± 0.4
PrimaryMetabolic Parameters - Fasting Glucose (mg/dl)

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

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Fasting Glucose (mg/dl)
mg/dlSmall SJLLarge SJL
Baseline99.0 ± 1.7101.2 ± 3.6
6 months84.5 ± 1.183.3 ± 0.8
PrimaryMetabolic Parameters - Insulin (mg/dl)

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

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Insulin (mg/dl)
mg/dlSmall SJLLarge SJL
Baseline27.0 ± 2.125.2 ± 1.6
6 months8.8 ± 0.910.5 ± 0.6
PrimaryMetabolic 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

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)
mg/dlSmall SJLLarge SJL
Baseline6.7 ± 0.56.2 ± 0.4
6 months1.8 ± 0.22.1 ± 0.1
PrimaryMetabolic Parameters - Cholesterol (mg/dl)

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

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Cholesterol (mg/dl)
mg/dlSmall SJLLarge SJL
Baseline201.6 ± 5.3203.9 ± 5.4
6 months157.0 ± 4.2159.5 ± 4.6
PrimaryMetabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)

Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)
mg/dlSmall SJLLarge SJL
Baseline51.4 ± 1.747.6 ± 1.6
6 months52.1 ± 1.647.1 ± 1.5
PrimaryMetabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)

Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)
mg/dlSmall SJLLarge SJL
Baseline118.0 ± 4.4119.8 ± 4.3
6 months86.0 ± 3.592.9 ± 3.8
PrimaryMetabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)

Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)
mg/dlSmall SJLLarge SJL
Baseline32.2 ± 2.636.4 ± 2.9
6 months19.3 ± 0.919.4 ± 1.1
PrimaryMetabolic Parameters - Triglycerides (mg/dl)

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

Time frame:
Baseline and 6 months
Reported as:
Mean · mg/dl
Metabolic Parameters - Triglycerides (mg/dl)
mg/dlSmall SJLLarge SJL
Baseline162.9 ± 10.6162.3 ± 9.0
6 months98.8 ± 5.796.0 ± 4.6
SecondaryFood 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).

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · grams/day
Food Consumption - Calories (Grams/Day)
grams/daySmall SJLLarge SJL
Baseline2185.0 ± 95.52565.6 ± 130.0
3 months823.8 ± 32.0889.7 ± 34.2
6 months937.7 ± 30.61091.9 ± 39.0
SecondaryFood 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).

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · grams/day
Food Consumption - Carbohydrate (Grams/Day)
grams/daySmall SJLLarge SJL
Baseline229.0 ± 9.4261.4 ± 13.7
3 months61 ± 3.170.7 ± 3.7
6 months68.8 ± 3.577.7 ± 3.8
SecondaryFood 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).

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · grams/day
Food Consumption - Total Fat (Grams/Day)
grams/daySmall SJLLarge SJL
Baseline97.3 ± 5.6116.5 ± 7.4
3 months32.2 ± 1.733.2 ± 1.9
6 months40.2 ± 1.749.5 ± 2.4
SecondaryFood 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).

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · grams/day
Food Consumption - Polyunsaturated Fat (Grams/Day)
grams/daySmall SJLLarge SJL
Baseline12.9 ± 0.915.9 ± 1.2
3 months4.5 ± 0.25.0 ± 0.3
6 months5.9 ± 0.37.8 ± 0.5
SecondaryFood 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).

Time frame:
Baseline, 3 and 6 months
Reported as:
Mean · grams/day
Food Consumption - Monounsaturated Fat (Grams/Day)
grams/daySmall SJLLarge SJL
Baseline30.1 ± 1.934.5 ± 1.9
3 months10.0 ± 0.610.2 ± 0.6
6 months12.8 ± 0.515.6 ± 0.9

Adverse events

Collected over Through study completion, an average of 1 year and 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Small and Large Social Jetlag0/122 (0%)0/122 (0%)0/122 (0%)

Baseline characteristics

Bariatric patients in six months follow - up after surgery

Age, Continuous
Age, Continuous(years)Small SJLLarge SJLTotal
Median33.5 (28 to 39)33 (28 to 39)33 (28 to 41.7)
Sex: Female, Male
Sex: Female, Male(Participants)Small SJLLarge SJLTotal
Female484694
Male121628
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Small SJLLarge SJLTotal
Count of participants——0
Social jetlag exposure
Social jetlag exposure(Minutes)Small SJLLarge SJLTotal
Median67 (43 to 107)67 (43 to 107)67 (43 to 107)
07

Study locations

1 site
  • Cibele Aparecida Crispim
    Uberlândia, Minas Gerais 38.405-320, Brazil
08

References and documents

Publications

  • 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 ↗

Study documents

  • Study protocol · Apr 3, 2021
  • Statistical analysis plan · Apr 3, 2021
  • Informed consent form · Apr 3, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03485352
Lead sponsor
Federal University of Uberlandia
Responsible party
Cibele Aparecida Crispim (Principal Investigator, Federal University of Uberlandia) — Principal investigator
First posted
Apr 2, 2018
Start date
Jun 5, 2017
Primary completion
Apr 30, 2018
Completion
Apr 30, 2019
Results posted
Apr 1, 2024
Last update
Apr 1, 2024

Study contacts

Cibele A Crispim, PhD
principal investigator · Federal University of Uberlandia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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