Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity

Plain-language guide to NCT07653464: early phase 1 non-randomized trial of Insulin (regular human), insulin resistance, prediabetes & type 2 diabetes, 64 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT07653464
Phase: early phase 1
Status: not yet recruiting
Start: 2026-12
Completion (planned or actual): 2031-06
Participants: 64 (estimated)
Design: non-randomized, open label (everyone knows who gets what), basic_science
Conditions studied: Obesity (BMI>30); Insulin Resistance
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) for insulin resistance, prediabetes & type 2 diabetes.

Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.

It had two arms (groups): Insulin (Doppler) (experimental) and Insulin (MRI) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 64 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: 18 to 65 years of age. BMI 30-45 kg/m2. Waist circumference ≥102 cm (men) or ≥88 cm (women). BMI 18-25 kg/m2. Waist circumference \<94 cm (men) and \<80 cm (women).

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: pregnancy, breastfeeding; unable to provide consent; diabetes or polycystic ovarian syndrome.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-12 with completion listed for 2031-06.

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: Amount of muscle sympathetic nerve activity (MSNA) (time frame: Change from baseline at minute 30). Amount of cerebral blood flow (time frame: Change from baseline at minute 30). Amount of leg blood flow (time frame: Change from baseline at minute 30).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin (regular human) in 64 people with insulin resistance, prediabetes & type 2 diabetes.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.

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.

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.