Weight Loss With Intensive Lifestyle Modifications Plus Bariatric Surgery Versus Liraglutide [amount hidden]

What Was Tested

This registered not phased trial tested Liraglutide for fat loss, obesity & body recomposition.

It had three arms (groups): Lifestyle modification (active comparator), one (experimental) and Sleeve Gastrectomy (active comparator).

The patients will undergo laparoscopic sleeve gastrectomy.

The registry classes the interventions as drug and other.

More on the Plan

Subjects with a body mass index (BMI) \>40 kg/m2 or \>35 kg/m2 in the presence of obesity complications are eligible for bariatric surgery 6 .

The largest portion of patients eligible for bariatric surgery but who are not willing to be operated or cannot undergo surgery for other reasons should be offered, however, with other therapeutic options.

In the medical arms the patients were also invited to contact the dietitian and the physician every week by email or by phone to assure a tight weight control.

The allocation of the patients, all of them eligible for bariatric surgery, was on a voluntary basis, i.e. they were invited to decide their allocation in one of the 3 arms of the study matched by BMI and age.

Who Took Part

75 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Liraglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2015-11-02 with completion listed for 2017-01-31.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change of baseline BMI (time frame: 1 year).

It also tracked 6 secondary outcomes, for example changes of baseline weight plasma, changes in body composition, changes in plasma glucose, changes in HOMA-IR, changes in blood pressure and changes in lipid profile.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Liraglutide in 75 people with fat loss, obesity & body recomposition.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research.