Clinical trial NCT03102697: Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity
Official title: Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons (Heliosphere Bag®) in the Treatment of Obesity: A Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Metabolic Syndrome
Keywords: Intragastric balloon
obesity
metabolic syndrome
bariatric surgery
Lead sponsor: Kaiser Clinic and Hospital
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese or overweight individuals eligible for gastric balloon placement and with no contraindications for the procedure will be recruited from the Mario Covas Hospital and the Kaiser Day Hospital.

Brief summary: This is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.

Detailed description: Intragastric balloon (IGB) implantation is a widely used technique to treat overweight subjects and those with mild obesity. The effectiveness of the air filled balloon (Heliosphere BAG®) in improving weight loss, reduction of BMI, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. Several methods are available for IGB placement and new techniques are being developed to reduce discomfort during and after the procedure. Thus, the use of an IGB as an effective method to avoid bariatric surgery is proposed. However, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established.

Our secondary objectives will be:

* Describe the weight loss, changes in the BMI and excess weight loss between the implantation of the first IGB until its removal;
* Describe changes in the components of the metabolic syndrome;
* Describe changes in blood pressure;
* Estimate the rate of early explant;
* Describe the conditions of surgery;
* Describe operative complications;
* To describe safety in the perioperative period, in the immediate postoperative period and in the late postoperative period

Eligibility criteria: Inclusion Criteria:

* Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).

Exclusion Criteria:

* Morbid obesity (BMI\>40kg/m2), operative contraindications.

Primary outcomes:
measure: Weight loss
timeFrame: 12 months
Secondary outcomes:
measure: Rate of early explant
timeFrame: 12 months
measure: Operative complications
timeFrame: Through endoscopy completion, an average of 2 hours
measure: Change in blood pressure
timeFrame: 12 months
measure: Changes Glycated hemoglobin (HbA1c)
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Caloric intake
timeFrame: 12 months
measure: Excess weight loss
timeFrame: 12 months
measure: Posoperative complications
timeFrame: Through posToperative period completion, an average of 72 hours after the termination of surgery
Other outcomes:
Locations:
city: Santo Andre
country: Brazil
facility: School of Medice of ABC
state: Sao Paolo
Study officials:
affiliation: School of Medicine of ABC, Santo Andre/SP Brazil
name: Eduardo Grecco, MD
role: STUDY_CHAIR
References: