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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Bariatric Surgery patients
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| Name | Affiliation | Role |
|---|---|---|
| Cibele A Crispim, PhD | Federal University of Uberlandia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cibele Aparecida Crispim | Uberlândia | Minas Gerais | 38.405-320 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32728839 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bariatric Surgery Patients | Patients undergoing bariatric surgery (sleeve or Bypass) 28 male and 94 woman with mean age of 33 years old. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Bariatric patients in six months follow - up after surgery
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| ID | Title | Description |
|---|---|---|
| BG000 | Small SJL | Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) |
| BG001 | Large SJL | Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The participants were categorised as follows: initially, the mean exposure to SJL of the three assessment periods was calculated. Subsequently, the median of this distribution was determined and used to categorise the participants into two groups: large exposure to SJL (mean exposure > median) or small exposure to SJL (mean exposure ≤ median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight in Kg | Anthropometric assessment will be evaluated using weight (kg). | 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. | Posted | Mean | Standard Error | Kg | Baseline, 3 and 6 months |
|
Through study completion, an average of 1 year and 5 months
The risks are that during blood collection it may eventually be painful for the volunteer causing bruises or swelling caused by blood collection, embarrassment '' shame'' for weight measurement and circumferences and during the application of questionnaires. Adverse events were evaluated and monitored throughout data collection,however none of these situations was identified during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Small and Large Social Jetlag | Patients who underwent bariatric surgery (Roux-en-Y gastric bypass or Sleeve - 77% female, aged 33 years (range 28-41)). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Cibele Crispim | Federal University of Uberlandia | 55 34 3218-2084 | cibelecrispim@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2021 | Apr 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2021 | Apr 4, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2021 | Apr 4, 2021 | ICF_002.pdf |
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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 |
| 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). | 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). | 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). | 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). | Baseline, 3 and 6 months |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
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| Sex: Female, Male | Brazilian bariatric patients | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Social jetlag exposure | The participants were categorised as follows: initially, the mean exposure to SJL of the three assessment periods was calculated. Subsequently, the median of this distribution was determined and used to categorise the participants into two groups: large exposure to SJL (mean exposure > median) or small exposure to SJL (mean exposure ≤ median). | Median | Inter-Quartile Range | Minutes |
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| Primary | BMI in Kg/m² | Anthropometric assessment will be evaluated using BMI (kg/m²). | 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. | Posted | Mean | Standard Error | Kg/m² | Baseline, 3 and 6 months |
|
|
|
| Primary | Waist Circumference in Centimeters (cm) | Anthropometric assessment will be evaluated using waist circumference (cm) | 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. | Posted | Mean | Standard Error | Centimeters | Baseline, 3 and 6 months |
|
|
|
| Primary | Hip Circumference in Centimeters (cm) | Anthropometric assessment will be evaluated using hip circumference (cm) | 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. | Posted | Mean | Standard Error | Centimeters | Baseline, 3 and 6 months |
|
|
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| Primary | Neck Circumference in Centimeters (cm) | Anthropometric assessment will be evaluated using neck circumference (cm) | 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 neck circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention. | Posted | Mean | Standard Error | Centimeters | Baseline, 3 and 6 months |
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| Primary | Metabolic Parameters - Fasting Glucose (mg/dl) | Metabolic parameters will be evaluated using fasting glucose (mg/dl) | 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 fasting glucose in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
|
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| Primary | Metabolic Parameters - Insulin (mg/dl) | Metabolic parameters will be evaluated using insulin (mg/dl) | 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 insulin in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
|
|
|
| Primary | 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 | 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 HOMA IR in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
|
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| Primary | Metabolic Parameters - Cholesterol (mg/dl) | Metabolic parameters will be evaluated using Cholesterol (mg/dl) | 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 cholesterol in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
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| Primary | Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) | Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl) | 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 HDL in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
|
|
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| Primary | Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) | Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl) | 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 LDL in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
|
|
|
| Primary | Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) | Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl) | 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 VLDL in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
|
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|
| Primary | Metabolic Parameters - Triglycerides (mg/dl) | Metabolic parameters will be evaluated using Triglycerides (mg/dl) | 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 triglycerides in the preoperative evaluation and sixth months after the surgical intervention. | Posted | Mean | Standard Error | mg/dl | Baseline and 6 months |
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| Secondary | 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). | 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 food consumption of calories in the preoperative evaluation and in the third and sixth months after the surgical intervention. | Posted | Mean | Standard Error | grams/day | Baseline, 3 and 6 months |
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| Secondary | 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). | 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 food consumption of the carbohydrate in the preoperative evaluation and in the third and sixth months after the surgical intervention. | Posted | Mean | Standard Error | grams/day | Baseline, 3 and 6 months |
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| Secondary | 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). | 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 food consumption of total fat in the preoperative evaluation and in the third and sixth months after the surgical intervention. | Posted | Mean | Standard Error | grams/day | Baseline, 3 and 6 months |
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| Secondary | 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). | 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 food consumption of Polyunsaturated fat in the preoperative evaluation and in the third and sixth months after the surgical intervention. | Posted | Mean | Standard Error | grams/day | Baseline, 3 and 6 months |
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| Secondary | 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). | 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 food consumption of Monounsaturated fat in the preoperative evaluation and in the third and sixth months after the surgical intervention. | Posted | Mean | Standard Error | grams/day | Baseline, 3 and 6 months |
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| 0 |
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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