NCT06774170Enrolling by invitation
Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery
Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Jan 2025
- Start date
- Apr 2024
- Primary completion date
- Nov 2025
- Lead sponsor
- Dokuz Eylul University
- Diseases
- Pancreatic cancer, Childhood cancers
- NCT number
- NCT06774170
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Apr 2024 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- The inclusion criteria for the particioants were; being over 18 years of age, being a smartphone user compatible with the Dexcom G6 application, having an internet connection, having a Mini Mental Test result of over 22 points for educated individuals and over 19 points for uneducated individuals, being willing to participate in the study, and having undergone pancreaticoduodenectomy.
- In the study, "able to swallow table" is not eligibility criteria due to tablet (medication) adherence is not assssed In the study, patients with and without preoperative diabetes mellitus type II were included in the sample. Block randomization was performed according to the presence of DM. Therefore, the presence of diabetes is not an exclusion criterion.
- In the literature, thyroid disease has not been identified as an exclusion criterion in studies related to pancreatogenic diabetes. The endocrinologist involved in this project did not find it necessary to add thyroid disease as an exclusion criterion.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dokuz Eylul University Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.