Skip to main content
OpenTrials
Completed

NCT Number: NCT04388059

Antrum Size, Glucagon-like Peptide 1 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect of Antrum Size on Glucagon-like Peptide 1 (GLP1) Levels and Glycemic Control After Sleeve Gastrectomy in Morbid Obese Diabetic Adolescents

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 14, 2020
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.