Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels
Primary Purpose
Bariatric Surgery Candidate, Obesity, Morbid, Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery Candidate
Eligibility Criteria
Inclusion Criteria:
- Adult
- male or female
- from 18 to 60 ages
- BMI: 40 kg/m2 or > 35 kg/m2
- comorbidities e.g., hypertension and DM
- conservative management for obesity failed in at least 2 years
Exclusion Criteria:
- BMI > 60
- history of bariatric surgery
- symptomatic reflux oesophagitis
- stomach cancer
- active peptic ulcer disease
- alcohol or drug abuse
- major psychological disturbance
- major eating troubles
- risky anesthesia
- risky surgery.
Sites / Locations
- Kafrelsheikh University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic sleeve gastrectomy
Arm Description
After sleeve gastrectomy, assessment of vitamin D, calcium and parathormone levels is performed.
Outcomes
Primary Outcome Measures
Vitamin D level assessment
Assessment of the vitamin D level after sleeve gastrectomy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05430932
Brief Title
Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels
Official Title
Effect Of Laparoscopic Sleeve Gastrectomy (LSG) on Vitamin D, Parathormone and Calcium Levels
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. The national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades.
the study aimed to assess the effect of Vit D supplementation on preventing altered levels of calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity, Morbid, Vitamin D Deficiency, Calcium Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Experimental
Arm Description
After sleeve gastrectomy, assessment of vitamin D, calcium and parathormone levels is performed.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy
Intervention Description
Laparoscopic resection of a part of the stomach to enable the patient to lose weight.
Primary Outcome Measure Information:
Title
Vitamin D level assessment
Description
Assessment of the vitamin D level after sleeve gastrectomy.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult
male or female
from 18 to 60 ages
BMI: 40 kg/m2 or > 35 kg/m2
comorbidities e.g., hypertension and DM
conservative management for obesity failed in at least 2 years
Exclusion Criteria:
BMI > 60
history of bariatric surgery
symptomatic reflux oesophagitis
stomach cancer
active peptic ulcer disease
alcohol or drug abuse
major psychological disturbance
major eating troubles
risky anesthesia
risky surgery.
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafr Al Sheikh
ZIP/Postal Code
33516
Country
Egypt
12. IPD Sharing Statement
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Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels
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