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Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial

Plain-language guide to NCT07007130: not phased randomized trial of Insulin (regular human), insulin resistance, prediabetes & type 2 diabetes, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07007130
Phase
not phased
Status
not yet recruiting
Start
2025-06-01
Completion (planned or actual)
2026-03-01
Participants
100 (estimated)
Design
randomized, quadruple-blind, prevention
Conditions studied
Prevention of Postoperative Adhesions
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

Patients with insulin resistance (IR) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation.

It had two arms (groups): Intervention group (active comparator) and Control group (sham comparator).

The registry classes the interventions as drug.

More on the Plan

The study will be conducted at a dr saed hospital and will enroll 100 female patients diagnosed with insulin resistance undergoing laparoscopy for infertility or chronic pelvic pain.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Women aged 18-40 years. Diagnosed insulin resistance (e.g., HOMA-IR \>2.5 or fasting insulin \>15 uIU/mL). Indicated for laparoscopy for infertility or pelvic pain. BMI 20-35 kg/m². Able and willing to give informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: history of peritonitis or major abdominal surgery in the past 6 months; known allergy or sensitivity to insulin; chronic steroid or immunosuppressive use.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-06-01 with completion listed for 2026-03-01.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Adhesion scoring at second-look laparoscopy (time frame: 4-6 weeks postoperatively).

It also tracked 4 secondary outcomes, for example Postoperative pain scores, Hypoglycemic events, Hypoglycemic events and Fertility rates.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 100 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.

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.