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Preoperative Condition in Giant Obese Patients
Plain-language guide to NCT02616003: phase 4 interventional trial of Liraglutide, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02616003
- Phase
- phase 4
- Status
- completed
- Start
- 2014-04
- Completion (planned or actual)
- 2018-01
- Participants
- 50 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Morbid Obesity; Bariatric Surgery Candidate
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Liraglutide.
The frequency of super-super obese who need immediate weight loss surgery is risen continuously.
For those patients a prior-to-surgery conditioning therapy is mandatory to gain technical and physical operability.
The exclusively well-established preliminary therapy so far was the intragastric balloon, which takes 7 months of treatment time.
It had 1 arm (groups): Super-super Obese Patients (other).
The registry classes the interventions as dietary supplement, drug and other.
More on the Plan
The investigators will combine this with a daily subcutaneous injection of Liraglutide.
Liraglutide is a GLP-1 analogue, which achieved meanwhile the FDA approval for weight loss treatment.
Who Took Part
Enrollment: 50 actual participants took part.
It was open to people of any sex.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Multimorbid, super-super obese patients.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: renal insufficiency iii.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-04 with completion listed for 2018-01.
It ran at 1 site in Germany.
Its stated primary purpose is other.
What Was Measured
Researchers chose this as the main measure: Operability (time frame: 21 days).
It also tracked 9 secondary outcomes, for example Chronic inflammation, Chronic inflammation II, Liver volume, Liver function, Pulmonary function and Hg A1c in %.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Liraglutide in 50 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.