Status:
WITHDRAWN
Use of Adjustable Gastric Band in Adolescents
Lead Sponsor:
University of Minnesota
Conditions:
OBESITY
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.
Detailed Description
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...
Eligibility Criteria
Inclusion
- BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5
Exclusion
- •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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01882049
Start Date
May 1 2016
End Date
May 1 2016
Last Update
May 16 2016
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414