Antrum Size, Glucagon-like Peptide 1 Levels and Glycemic Control After Sleeve Gastrectomy in Morbid Obese Diabetic Adolescents

Adolescent Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388059
• Other study ID #: sleeve gastrectomy adolescent
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Obesity
• Pediatric Obesity

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucagon-like peptide 1 (GLP1) levels in morbid obese diabetic adolescents.	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
Primary	glycemic control in morbid obese diabetic adolescents.	glycemic control in morbid obese diabetic adolescents after laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus	24 months post-operative
Secondary	weight loss in morbid obese diabetic adolescents.	weight loss in morbid obese diabetic adolescents after laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus	24 months post-operative