Obesity Clinical Trial
Official title:
The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study
This protocol describes a feasibility pilot study preceding a randomized clinical study that
aims at comparing the Elipse intragastric Balloon system to other invasive obesity
techiniques.
The current pilot study is investigating the feasibility and efficacy of the Elipse Balloon
system in 20 patients in Norway.
The primary aims of the pilot study are to streamline the infrastructure, machinery, and
clinical experience with the balloon before the start of the randomized trial. The inclusion
and exclusion criteria, and measurement points will be similar for the two studies.
The primary endpoints of the pilot study are to ascertain the feasibility of
1. Patient recruitment and informed consent process
2. Balloon insertion procedure
3. Follow-up of patients for the period of balloon therapy (one balloon)
4. Data gathering, data management, and endpoint evaluation
5. Adverse event evaluation of balloon insertion and therapy Secondary endpoints are weight
loss, HBA1c
Eligible Patients Eligible patients are adults who have been referred for obesity treatment
to one of the participating obesity centres and meet all of the inclusion criteria and none
of the exclusion criteria.
Inclusion criteria
1. adults 18 year or older with BMI ≥30 and ≤40 kg/m2, and a diagnosis of type 2 diabetes.
Feasibility of the intervention will be assesssed by the investigators. Subjects will be
carefully monitored during the study for possible adverse events (AEs) and will be advised to
contact the study investigator in case of symptoms of possible adverse events.. During each
clinical follow-up visit, the investigator will determine AE occurrences. Each adverse event
is considered to be either anticipated or unanticipated as described below.
An AE is any adverse change from the subject's baseline (pre-treatment) condition, including
a concurrent illness, occurring during the course of the study whether or not considered
related to the study intervention (balloon or surgery). Therefore, an AE can be any
unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or
disease temporally associated with the study treatment, whether or not related to the
procedure.
All adverse events are described by the local study investigator using the electronic patient
record system at the participating site. Adverse events will also be collected once yearly
through searches in local and national patient registries (hospital discharge and diagnosis
registry, Norwegian cause-of-death registry, Norwegian cancer registry).
AEs are categorized as serious or non-serious. Serious Adverse Event (SAE) are those leading
to
- unplanned medical or surgical intervention
- unplanned hospitalization (including emergency department visit)
- prolonged duration of planned hospitalization (>24hrs)
- life threatening illness or injury
- permanent impairment of a body structure or a body function
- Death Planned hospitalization for a pre-existing condition, or a procedure required by
the protocol, without serious deterioration in health, is not considered a serious
adverse event.
Non-Serious Adverse Events:
Adverse events that do not meet the definition of SAEs.
AE evaluation Each reported SAE is reviewed by an adverse event evaluation committee. The
committee consist of three individuals with a medical background relevant for the trial and
its interventions. The committee is not blinded to treatment arm as this is not feasible
given the nature of the trial interventions and the expected grade of details to review to
make a decision. Each member of the AE evaluation committee reviews each case independently.
Agreement of whether the SAE is due to the intervention or not (yes, no, An SAE report is
submitted to the PIs and the company one time each year during the course of the trial.
Participants will be examined by the study investigators 1 to 3 weeks prior to treatment
start (baseline visit), and at weeks 4, 8, 12, 16, 26 and 52 after treatment start.
At the baseline visit, demographic data and medical history is assessed.
All visits include a clinical examination with measurements of body weight, anthropometric
measures and blood pressure, laboratory analyses, a registration of supplementation and
prescription and over-the-counter drug use, and registration of complications and side
effects.
Body weight and composition will be measured with patients wearing light clothing and no
shoes using bioelectrical impedance analysis. Anthropometric measures will be recorded with
patients in an upright position. Height will be measured using wall mounted stadiometers;
waist circumference (WC) will be measured at the point midway between the lowest rib margin
and the iliac crest. Height and circumferences will be measured to nearest 0.5 cm and weight
to the nearest 0.1 kg.
The following laboratory analysis will be performed: hemoglobin; white blood cell count;
platelet count; international normalized ratio; C-reactive protein; blood glucose, HbA1c;
insulin, C-peptide; anti-GAD; anti-IA2; sodium; potassium; phosphate; chloride; magnesium;
serum iron; ferritin; transferrin; calcium; 1,25 dihydroxyvitamin D; 25 hydroxyvitamin D;
parathyroid hormone; thiamine; B12; folate; creatinine; bilirubin; albumin; total protein;
alanine aminotransferase; aspartate aminotransferase; alkaline phosphatase A; gamma-glutamyl
transpeptidase; amylase; lactate dehydrogenase; triglycerides; total cholesterol; HDL
cholesterol; LDL cholesterol; unbound thyroxine; thyroid stimulating hormone;
;
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