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New treatment option for Obesity
Official title Small Bowel Diversion
ClinicalTrials.gov ID: NCT06374368
What this study is testing
- What it's testing
- In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries.
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 65
You may be able to join if
- age 18-65 years at screening;
- Body mass index ≥30 or ≤50kg/m2;
- If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication;
- If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment.
You likely can't join if
- Body Mass Index \>50 or \<30 kg/m2;
- Diagnosis of Type 2 diabetes less than 6 months;
- History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease);
- History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin;
- Ongoing systemic infection;
- Chronic pancreatitis;
See the full eligibility criteria
- age 18-65 years at screening;
- Body mass index ≥30 or ≤50kg/m2;
- If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication;
- If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment.
- Body Mass Index \>50 or \<30 kg/m2;
- Diagnosis of Type 2 diabetes less than 6 months;
- History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease);
- History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin;
- Ongoing systemic infection;
- Chronic pancreatitis;
- Chronic liver disease of any cause;
- Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis);
- Any history of an eating disorder within the past 5 years;
- Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism);
- uncontrolled hypertension (systolic Blood Preassure \> 150 mm Hg or diastolic Blood Preassure \> 100 mm Hg).
The study team makes the final eligibility decision.
Where it's taking place
- Ostrava, Czechia
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ostrava, Czechia. 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.