Adolescent Weight Loss Surgery study

Not Applicable

Active, not recruiting

• Conditions: Morbid obesity; pre-diabetes type 2 diabetes; type 2 diabetes; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12620000650998
• Lead Sponsor: Aotearoa Clinical Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-05
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome:<br>Incidence of diabetes and pre-diabetes as determined by a fasting oral glucose tolerance test.[ After baseline (pre-surgery) and at week 52 (end of study)]

Secondary Outcome Measures

Name	Time	Method
Weight change measured by digital scales[ Weight change will be measured at each study visit.];Glycaemic control as measured by glycated haemoglobin level (HbA1c) using a DCA machine[ Screening (pre-surgery), and weeks 24, 52 (post surgery)];Mean blood pressure as measured by the mean of sitting systolic & diastolic BP levels using a digital machine (Dynamap).[ Baseline, weeks 1,12, pre- surgery and then post-surgery during follow-up at weeks1,12,36,52];Dyslipidaemia measured using blood test and laboratory evaluation to determine fasting cholesterol, HDL-c, and triglyceride levels [ Baseline, day of surgery for those having surgery, weeks 24 and 52];Quality of life as measured by the IWQOL-Lite (Impact of Weight Reduction Questionnaire) and SF-36. [ baseline, the post surgery weeks 1,12,24,36,52]