Duodenal pulsENDO for early type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm feasibility study designed to test the safety and potential efficacy of the pulsENDO endoscopic therapy in adults with a recent T2DM diagnosis. Participants will be followed for 6 months for the primary endpoint and up to 2 years total. The trial enrolls individuals who have diabetes for 2 years or less, are on 0–1 oral diabetes medications, and have an HbA1c of 7.5% or lower. Exclusion criteria include prior pulsENDO or similar procedures, certain GI conditions, and coagulopathy or active inflammatory GI disease. The study is conducted at the Chinese University of Hong Kong with the lead sponsor centralized there.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Duration of T2DM \</= 2 years
* HbA1c \</= 7.5%
* On 0-1 oral diabetes medications

Exclusion Criteria:

* Previous treatment with pulsENDO or similar procedure
* Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO
* Type I DM, DM secondary to specific disease or having any history of ketoacidosis
* Fasting C-peptide level \<0.5ug/L
* Any inflammatory disease of the gastrointestinal tract such as Crohn's disease
* Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy
* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and/or there is a need or expected need to use during the study period
* Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
* Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month
* Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.
* Patients with contra-indications to endoscopy
* Malignancy
* Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
* Pregnant or breast feeding
* ASA grade IV \& V
* Mental or psychiatric disorder; Drug or alcohol addiction
* Other cases deemed by the examining physician as unsuitable for safe treatment
* Refusal to participate

Where it's running

• Chinese University of Hong Kong
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Stephen Ng, FRCSEd(Gen) — Prince of Wales Hospital, the Chinese University of Hong Kong
• Study coordinator: Stephen Ng, FRCSEd(Gen)
• Email: stephenng@surgery.cuhk.edu.hk
• Phone: +85235052956

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Differentiating heart disease in autoimmune vs. type 2 diabetes

  This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.

  Recruiting University of Roma La Sapienza · Rome, Roma · NCT07911007

• High BMI and periodontitis in Thai adults under 60

  This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.

  Recruiting Mahidol University · Bangkok, Ratchathewi · NCT07880717

• Reset-INSPIRE: See if CGM can reveal insulin sensitivity in people at risk for MASLD

  This study tests whether real-time CGM data can accurately reflect insulin sensitivity in adults without diabetes who are at risk for MASLD.

  Recruiting National University Health System, Singapore · Singapore, Singapore · NCT07861191

• Telemonitoring for Better Glycemic Control in Tunisian Adults with Diabetes

  This trial tests whether remote diabetes management through a mobile app and web platform can improve blood sugar control in adults with diabetes in Tunisia compared with standard care.

  Recruiting University of Monastir · Monastir · NCT07774078

• Rapid guideline-based therapy after a heart attack

  This project tests whether starting guideline-driven secondary prevention soon after a heart attack helps people who had PCI reach better risk-factor control and fewer heart events.

  Recruiting Zuyderland Medisch Centrum · Heerlen, Limburg · NCT07773272

• Impact of a Clinical Information System on hospital outcomes for adults with chronic diseases

  This study tests whether implementing a Clinical Information System helps reduce readmissions or death within 30 days after hospital discharge for adults with chronic conditions in Alberta.

  Recruiting University of Calgary · Calgary, Alberta · NCT07609381

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.