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

NCT04388059 | Completed

• 1 other identifier: sleeve gastrectomy adolescent
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adolescent Obesity

Keywords

Laparoscopic sleeve gastrectomy; obesity; adolescent; glucagon-like peptide 1; glycemic control; diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• weight loss in morbid obese diabetic adolescents.

  24 months post-operative

Study Arms (2)

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.

Procedure: Laparoscopic sleeve gastrectomy

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.

Procedure: Laparoscopic sleeve gastrectomy

Interventions

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.

Transection at 2 cm from the pylorus; Transection at 5 cm from the pylorus

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

morbid obese diabetic adolescents

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• Shehata MA, Elhaddad A, El-Attar AA, Shehata SM. The Effect of Antrum Size on Weight Loss, Glucagon-Like Peptide-1 (GLP-1) Levels, and Glycemic Control Following Laparoscopic Sleeve Gastrectomy in Adolescents with Obesity and Type 2 Diabetes. Obes Surg. 2021 Oct;31(10):4376-4385. doi: 10.1007/s11695-021-05590-9. Epub 2021 Aug 5.

  PMID: 34355337 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

glucagon-like peptide 1 HbA1c (glycated hemoglobin) body mass index

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric surgery

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 14, 2020

Record last verified: 2020-05