A pilot study to evaluate the benefit of intensive lifestyle intervention (low calorie diet and exercise) with or without bariatric (weight-reduction) surgery in high-risk adolescents with morbid obesity.

Aotearoa Clinical Trials0 sites20 target enrollmentJune 5, 2020

Overview

No summary available.

Registry

who.int

Start Date

June 5, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Aotearoa Clinical Trials

•1\.Be aged between 15 years 9 months and 18 years inclusive
•2\.Have been diagnosed with morbid obesity defined as a body mass index (BMI) \>35 kg/m2 at the baseline visit.
•3\.Have pre\-diabetes or type 2 diabetes mellitus as confirmed by oral glucose tolerance test at the baseline visit.
•4\.Provide written informed consent to participate in the study

•1\.History of type 1 diabetes defined as age of onset \<20 years and/or history of continuous treatment with insulin since diagnosis and/or positive antibodies to glutamic acid decarboxylase \[GAD] or islet tyrosine phosphatase 2 \[IA2] at baseline.
•2\.History of drug or alcohol abuse
•3\.Pregnancy
•4\.Serious co\-morbid conditions that are likely to affect survival
•5\.Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.