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Regional Lipolysis Insulin Regulation

Plain-language guide to NCT06392854: early phase 1 non-randomized trial of Insulin (regular human), 48 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06392854
Phase
early phase 1
Status
recruiting participants
Start
2024-05-01
Completion (planned or actual)
2028-06
Participants
48 (estimated)
Design
non-randomized, 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

The trial (early phase 1) is built around Insulin (regular human).

Adults who gain most of their excess weight in the abdominal area typically do not respond to insulin in the same way as lean adults.

Researchers are trying to understand why fat tissue responds differently in people with different body types.

It had two arms (groups): obesity status (other) and lean (other).

Obesity.

Non-obese.

The registry classes the interventions as drug.

More on the Plan

Measure regional free fatty acid (FFA) release in volunteers with and without UBO under two different conditions that suppress lipolysis and a condition that markedly stimulates lipolysis.

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Overweight/Obese volunteers will have a BMI 29.0 - 37.0 kg/m2. Female subjects are eligible if they meet the following criteria:. Are not pregnant or nursing. All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test day of admission for inpatient study visit.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: individuals with a history of a disease process such as:; ischemic heart disease; atherosclerotic valvular disease.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2024-05-01 with completion listed for 2028-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: palmitate release (time frame: The study will be conducted in a single day and will last approximately 6 hours).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin (regular human) in 48 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

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.