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New treatment option for Obesity Type 2 Diabetes Mellitus
Official title Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM
ClinicalTrials.gov ID: NCT07660445
What this study is testing
- What it's testing
- This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- BMI \>/= 27kg/m2
- Known T2DM
- Individualized Metabolic Surgery (IMS) score 25-115
- HbA1c \<11% (people on oral glucose lowering drug(s) or HbA1c \<8% (people on insulin)
You likely can't join if
- Previous treatment with ReCET, ESG or similar procedure
- Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET...
- Type 1 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...
See the full eligibility criteria
- BMI \>/= 27kg/m2
- Known T2DM
- Individualized Metabolic Surgery (IMS) score 25-115
- HbA1c \<11% (people on oral glucose lowering drug(s) or HbA1c \<8% (people on insulin)
- Previous treatment with ReCET, ESG or similar procedure
- Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG
- Type 1 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 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
- Patients with cirrhosis due to causes other than MASLD
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.