Obesity Clinical Trial
Official title:
Endoscopic Sleeve Gastroplasty in Comparison With Laparoscopic Sleeve Gastrectomy in Terms of Short-Term Nutritional Outcomes
NCT number | NCT04264364 |
Other study ID # | ESGvsLSG |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 16, 2019 |
Est. completion date | November 25, 2019 |
Verified date | February 2020 |
Source | King Saud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To assess endoscopic sleeve gastroplasty in comparison to laparoscopic sleeve gastrectomy before and 3 months after the procedure in terms of multiple nutrition-related factors, quality of life, weight and other related parameters.
Status | Completed |
Enrollment | 57 |
Est. completion date | November 25, 2019 |
Est. primary completion date | November 25, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult (= 18 years old) - Willingness and ability to participate - Males and females - Non-pregnant Exclusion Criteria: - Children (<18 years old) - Pregnant |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | New You Medical Center | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Saud University | King Saud Medical City |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight Loss | Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram) | 3 months | |
Primary | Percentage of total weight loss (%TWL) | %TWL = [(baseline weight in kilogram - weight at 3 months in kilogram) ÷ baseline weight in kilogram] | 3 months | |
Primary | Percentage of excess weight loss (%EWL) | %EWL = [percentage of weight lost compared with excess weight, which is defined as baseline weight in kilogram - the weight corresponding to a BMI of 25 kg/m^2 in kilogram]) | 3 months | |
Primary | Waist Circumference | Waist Circumference in centimeters | 3 months | |
Primary | body fat percentage change | change in body fat percentage between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device | 3 months | |
Primary | fat mass change | change in fat mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device | 3 months | |
Primary | fat mass index change | change in fat mass index in kg/m^2 between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device | 3 months | |
Primary | fat free mass change | change in fat free mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device | 3 months | |
Primary | fat free mass index change | change in fat free mass index in kg/m^2 between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device | 3 months | |
Primary | skeletal muscle mass change | change in skeletal muscle mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device | 3 months | |
Primary | Dietary habits | Assessment of dietary habits using the How Healthy Is Your Diet questionnaire, developed by the British Heart Foundation 2012 The score is from 0 minimum to 29. Higher score correlates with better dietary habits. |
3 months | |
Primary | 24-hour dietary recall | Assessment of nutritional intake with 24-hour dietary recall form | 3 months | |
Primary | 3-day dietary record | Assessment of nutritional intake with 3-day dietary record | 3 months | |
Primary | Change in quality of life after procedure | Moorehead-Ardelt Quality of Life Questionnaire II scoring using Moorehead-Ardelt Quality of Life Questionnaire II Self Esteem and Activity Levels SCORING KEY minimum score is -3 and maximum score is 3 a higher score means a better outcome. | 3 months | |
Primary | Cholesterol Biochemical assessment (laboratory assessment) | Cholesterol in milligrams per deciliter (< 200 Desirable) | 3 months | |
Primary | Alanine Aminotransferase Biochemical assessment (laboratory assessment) | Alanine Aminotransferase in units per liter (up to 33) | 3 months | |
Primary | Gamma glutamyl transferase Biochemical assessment (laboratory assessment) | Gamma glutamyl transferase in units per liter (< 40) | 3 months | |
Primary | sodium Biochemical assessment (laboratory assessment) | sodium in millimoles/liter (136-145) | 3 months | |
Primary | platelets Biochemical assessment (laboratory assessment) | platelets in cmm (150.0-450.0) | 3 months | |
Primary | MCH Biochemical assessment (laboratory assessment) | MCH in picograms per cell (25.00-32.00) | 3 months | |
Primary | potassium Biochemical assessment (laboratory assessment) | potassium in millimoles/liter (3.5-5.1) | 3 months | |
Primary | MCV Biochemical assessment (laboratory assessment) | MCV in femtoliters per cell (76.00-97.00) | 3 months | |
Primary | MCHC Biochemical assessment (laboratory assessment) | MCHC in grams per deciliter (31.80-35.40) | 3 months | |
Primary | Chloride Biochemical assessment (laboratory assessment) | Chloride in millimoles/liter (97-111) | 3 months | |
Primary | creatinine Biochemical assessment (laboratory assessment) | creatinine in mg/dL (44-80) | 3 months | |
Primary | WBC Biochemical assessment (laboratory assessment) | WBC in × 10^9/L (4.00-11.00) | 3 months | |
Primary | RBC Biochemical assessment (laboratory assessment) | RBC in million mcL (3.80-5.80) | 3 months | |
Primary | HCT Biochemical assessment (laboratory assessment) | HCT in % (36.00-46.00) | 3 months | |
Primary | serum glucose Biochemical assessment (laboratory assessment) | serum glucose in mg/dL (70-150) | 3 months | |
Primary | serum TSH Biochemical assessment (laboratory assessment) | serum TSH in milli-international units per liter (0.38-5.33) | 3 months | |
Primary | hemoglobin Biochemical assessment (laboratory assessment) | hemoglobin in grams per deciliter (12.00-16.00) | 3 months | |
Primary | Eosinophils Biochemical assessment (laboratory assessment) | Eosinophils in cells per microliter (0.00-6.00) | 3 months | |
Primary | monocytes Biochemical assessment (laboratory assessment) | monocytes in percent (0.00-13.70) | 3 months | |
Primary | INR plasma ratio Biochemical assessment (laboratory assessment) | INR plasma ratio (no units) | 3 months | |
Primary | Basophils Biochemical assessment (laboratory assessment) | Basophils in basophils per microliter (0.00-1.00) | 3 months | |
Primary | MPV Biochemical assessment (laboratory assessment) | MPV in fl (7.20-11.10) | 3 months | |
Primary | RDW Biochemical assessment (laboratory assessment) | RDW in % (12.40-16.20) | 3 months | |
Primary | lymphocytes Biochemical assessment (laboratory assessment) | lymphocytes in % (15.00-50.00) | 3 months | |
Primary | neutrophils Biochemical assessment (laboratory assessment) | neutrophils in cells/µL (40.00-75.00) | 3 months |
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