Use of Adjustable Gastric Band in Adolescents



Status:Not yet recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 18
Updated:4/2/2016
Start Date:May 2015
End Date:May 2016
Contact:Danette Oien
Email:oienx003@umn.edu
Phone:612 625 8413

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Use of the REALIZE™ Adjustable Gastric Band (Model 2200-X) in Adolescents

This study is to investigate the use the adjustable gastric band for the treatment of
obesity in adolescents.

Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts
of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken
in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to
help the participant loose weight along with healthy eating, diet and exercise. This study
involves minimally invasive laparoscopic surgery to place the adjustable band around the
upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball.
One end of the band ends with a flat balloon that goes around the upper part of the stomach.
The opening from this small stomach can be changed to allow more or less food into the
intestine depending on the amount eaten and the amount of weight lost.

The other end of the of the band ends in a filling port through which saline solution is
pumped with a needle through an attached tube to inflate or deflate the balloon. The filling
port is attached to the wall of the abdomen under the skin. Because the flow of food is
regulated by the band, most people feel full faster. This is how the appetite for food is
controlled and the why the person is likely to eat less with the band in place.

Food is digested through the normal digestive process.

Inclusion Criteria:

BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5

Exclusion Criteria:

- •Hypertension: Systolic blood pressure (SBP) of 140 mm Hg

- Hyperlipidemia: hyperlipidemia depends on

- Obstructive Sleep Apnea:

- Metabolic Syndrom: The presence of any three of the following: abdominal obesity
- dimensons for children? triglycerides -cholesterol -

- fasting glucose

- blood pressure

- overweight

- Non-surgical means of weight reduction failure of

- Significant psychopathology (absence of ) that could limit the subject's ability
to understand the procedure, comply with medical, surgical, and/or behavioral
recommendations, as documented during screening assessment;

- Agrees to refrain from any type of reconstructive surgery that would affect body
weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of
excess skin for three years following SAGB placement; and

- Candidate for surgical weight loss intervention (i.e., meets accepted health
criteria for major surgery.
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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