- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388059
Antrum Size, Glucagon-like Peptide 1 Levels and Glycemic Control After Sleeve Gastrectomy in Morbid Obese Diabetic Adolescents
May 11, 2020 updated by: Mohamed Ali Shehata, Tanta University
Effect of Antrum Size on Glucagon-like Peptide 1 (GLP1) Levels and Glycemic Control After Sleeve Gastrectomy in Morbid Obese Diabetic Adolescents
Childhood obesity can adversely affect every organ and often has serious consequences.
Compare the effect of transection at 2cm vs at 5cm from the pylorus during laparoscopic sleeve gastrectomy on the postoperative weight loss, glucagon-like peptide 1 levels and the glycemic control in morbid obese diabetic adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a retrospective sub-analysis included 18 type 2 diabetic morbidly obese adolescents of both genders from a larger study (performed on 67 patients between December 2014 and December 2015) conducted at pediatric surgery unit, surgical department, Egypt.
They were divided in 2 groups, done by 2 surgeons, group A (8 patients) the first stable line was at 2 cm from the pylorus, and group B (10 patients) at 5 cm from the pylorus.
Study Type
Observational
Enrollment (Actual)
18
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
morbid obese diabetic adolescents
Description
Inclusion Criteria:
- Adolescent, children (more than 12 years or less than 20 years), with BMI of at least 40 kg/m2, or 35 kg/m2 with an associated co-morbidity (e.g. hypertension, diabetes, dyslipidemia, obstructive sleep apnea, left ventricular hypertrophy, nonalcoholic steatohepatitis, orthopedic problems). Those with failure to achieve clinically significant weight loss (10% of baseline body weight) despite strict participation for at least 6 months in a formal weight management program were included in the study.
Exclusion Criteria:
- Adults, children (less than 12 years or more than 20 years) or their family who do not understand risks and benefits of the intervention, adolescents who are not autonomously motivated to consider operation, those have unrealistic expectations for results of the surgical intervention, or their parents, families or patients who cannot strictly comply with the postoperative nutritional recommendations and long-term medical and nutritional monitoring, presence of a medically correctable cause of obesity (relative contraindication), existence of a medical, psychiatric, or cognitive condition as attention deficit hyperkinetic disorders (ADHD) which may impair the ability of patient to assent to surgery or to adhere to postoperative dietary and medication regimen (relative contraindication), illicit substance abuses in preceding year, lactating, pregnant, or plans for pregnancy in upcoming 2 years and patients refuse to participate were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Transection at 2 cm from the pylorus
the effect of transection at 2 cm from the pylorus during Laparoscopic sleeve gastrectomy on the postoperative weight loss, GLP1 levels and the glycemic control in morbid obese diabetic adolescents.
|
Laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus on the postoperative weight loss, GLP1 levels and the glycemic control in morbid obese diabetic adolescents.
|
Transection at 5 cm from the pylorus
the effect of transection at 5 cm from the pylorus during Laparoscopic sleeve gastrectomy on the postoperative weight loss, GLP1 levels and the glycemic control in morbid obese diabetic adolescents.
|
Laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus on the postoperative weight loss, GLP1 levels and the glycemic control in morbid obese diabetic adolescents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glucagon-like peptide 1 (GLP1) levels in morbid obese diabetic adolescents.
Time Frame: 24 months post-operative
|
glucagon-like peptide 1 (GLP1) levels in morbid obese diabetic adolescents after laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus
|
24 months post-operative
|
glycemic control in morbid obese diabetic adolescents.
Time Frame: 24 months post-operative
|
glycemic control in morbid obese diabetic adolescents after laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus
|
24 months post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight loss in morbid obese diabetic adolescents.
Time Frame: 24 months post-operative
|
weight loss in morbid obese diabetic adolescents after laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus
|
24 months post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
May 11, 2020
First Posted (Actual)
May 14, 2020
Study Record Updates
Last Update Posted (Actual)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 11, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sleeve gastrectomy adolescent
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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