N/A
N=122
Influence of the Sleep Pattern in Patients Submitted to Bariatric Surgery
Bariatric Surgery Candidate
Bottom Line
View on ClinicalTrials.gov: NCT03485352 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Weight in Kg — 111.4; 116.4; 89.7; 93.5 Kg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Federal University of Uberlandia
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight in Kg |
111.4; 116.4; 89.7; 93.5; 77.5; 84.2 | — |
| PRIMARY BMI in Kg/m² |
40.8; 41.8; 32.9; 33.6; 28.7; 30.2 | — |
| PRIMARY Waist Circumference in Centimeters (cm) |
109.3; 110.0; 94.1; 95.1; 85.5; 88.4 | — |
| PRIMARY Hip Circumference in Centimeters (cm) |
128.9; 131.4; 114.9; 117.8; 105.8; 109.9 | — |
| PRIMARY Neck Circumference in Centimeters (cm) |
39.2; 39.4; 36.0; 36.3; 34.4; 35.1 | — |
| PRIMARY Metabolic Parameters - Fasting Glucose (mg/dl) |
99.0; 101.2; 84.5; 83.3 | — |
| PRIMARY Metabolic Parameters - Insulin (mg/dl) |
27.0; 25.2; 8.8; 10.5 | — |
| PRIMARY Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) |
6.7; 6.2; 1.8; 2.1 | — |
| PRIMARY Metabolic Parameters - Cholesterol (mg/dl) |
201.6; 203.9; 157.0; 159.5 | — |
| PRIMARY Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) |
51.4; 47.6; 52.1; 47.1 | — |
| PRIMARY Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) |
118.0; 119.8; 86.0; 92.9 | — |
| PRIMARY Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) |
32.2; 36.4; 19.3; 19.4 | — |
| PRIMARY Metabolic Parameters - Triglycerides (mg/dl) |
162.9; 162.3; 98.8; 96.0 | — |
| SECONDARY Food Consumption - Calories (Grams/Day) |
2185.0; 2565.6; 823.8; 889.7; 937.7; 1091.9 | — |
| SECONDARY Food Consumption - Carbohydrate (Grams/Day) |
229.0; 261.4; 61; 70.7; 68.8; 77.7 | — |
| SECONDARY Food Consumption - Total Fat (Grams/Day) |
97.3; 116.5; 32.2; 33.2; 40.2; 49.5 | — |
| SECONDARY Food Consumption - Polyunsaturated Fat (Grams/Day) |
12.9; 15.9; 4.5; 5.0; 5.9; 7.8 | — |
| SECONDARY Food Consumption - Monounsaturated Fat (Grams/Day) |
30.1; 34.5; 10.0; 10.2; 12.8; 15.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03485352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.