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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.