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To Determine Tolerability to Glucagon Infusion in Obese Subjects
Plain-language guide to NCT02817659: phase 1 interventional trial of Glucagon, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02817659
- Phase
- phase 1
- Status
- active, not recruiting
- Start
- 2016-11-01
- Completion (planned or actual)
- 2017-01-13
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Glucagon.
To further understand the tolerability of glucagon.
It had 1 arm (groups): Glucagon Infusion (experimental).
The registry classes the interventions as drug.
More on the Plan
To determine the tolerability of glucagon infusion administered in an escalating step-wise manner in healthy obese subjects.
Who Took Part
20 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 18-55 years, inclusive. BMI ≥27 to ≤40 kg/m2. Subject is judged to be non-diabetic and in good health on the basis of medical history, physical examination, electrocardiogram, and routine laboratory data. Subject understands the procedures and agrees to participate in the study program by giving written informed consent, and is willing to comply with the trial restrictions. Subject is willing to avoid alcohol consumption for 48 hours prior to the inpatient study visit.
The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: history of bariatric surgery; history of irritable bowel disease, recurrent nausea or vomiting; self-reported history of hepatitis b, hepatitis c, or hiv.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Glucagon 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 2016-11-01 with completion listed for 2017-01-13.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Glucagon in 20 people.
Its size is small, so on its own it can only give an early look.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Glucagon compound page, all human trials.
Our Notes on the Compound
Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.
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.