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New treatment option for Diabetes Type 2
Official title Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
ClinicalTrials.gov ID: NCT07350967
What this study is testing
- What it's testing
- English, Hindi and Gujarati
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- Participants are willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥ 25 years to ≤ 65 years inclusive at the time of informed consent
- BMI 30-50
- Prior sleeve gastrectomy (\> 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c \> 6.5%) or weight regain
- T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for \> 6M and \ 6.5 %
You likely can't join if
- Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months
- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- Current enrolment in another research study or previous participation within 30 days of enrolment
- Use of injectable insulin
- Uncontrolled T2DM
- Uncontrolled hypertension, dyslipidemia, or sleep apnea
See the full eligibility criteria
- Participants are willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥ 25 years to ≤ 65 years inclusive at the time of informed consent
- BMI 30-50
- Prior sleeve gastrectomy (\> 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c \> 6.5%) or weight regain
- T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for \> 6M and \ 6.5 %
- Agrees to abstain from any form of additional bariatric or reconstructive surgery that could influence body weight for a duration of 1 year
- Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months
- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- Current enrolment in another research study or previous participation within 30 days of enrolment
- Use of injectable insulin
- Uncontrolled T2DM
- Uncontrolled hypertension, dyslipidemia, or sleep apnea
- Current history of injected Glucagon Like Peptide 1 (GLP1)
- Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at...
- History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging
- Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures
- Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures
- History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for...
- Refractory gastroesophageal reflux disease (GERD)
- Barrett's esophagus
- Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques
- Presence of an implantable pacemaker or defibrillator
- Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses...
The study team makes the final eligibility decision.
Where it's taking place
- Ahmedabad, Gujarat, India
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, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahmedabad, Gujarat, India. 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.