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New treatment option for Obesity; Drug
Official title Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
ClinicalTrials.gov ID: NCT06431308
What this study is testing
- What it's testing
- The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- individuals aged ≥ 18 years
- eligible to receive AOM [i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes...
- who can read and speak Hebrew.
You likely can't join if
- Contraindications or precautious for treatment with Wegovy© or Mounjaro© [i.e., personal or family history of medullary thyroid cancer (MTC)...
- previous bariatric surgery or endo-bariatric procedure
- presence of chronic pancreatitis
- treatment with AOM within a month before enrollment
- patients with type 1 diabetes mellitus
- patients who underwent other major GI surgery prior to medication treatment
See the full eligibility criteria
- individuals aged ≥ 18 years
- eligible to receive AOM [i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver...
- who can read and speak Hebrew.
- Contraindications or precautious for treatment with Wegovy© or Mounjaro© [i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome...
- previous bariatric surgery or endo-bariatric procedure
- presence of chronic pancreatitis
- treatment with AOM within a month before enrollment
- patients with type 1 diabetes mellitus
- patients who underwent other major GI surgery prior to medication treatment
- patient with underlying GI disease [e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)]
- a positive diagnosis of small-intestinal bacterial overgrowth (SIBO)
- patients with active gastritis, gastroenteritis
- chronic usage of promotility drugs or laxatives
- patients with uncontrolled mental illness
- significant cognitive deterioration
- alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men . In addition, participants who decide not to initiate or stop Wegovy© or Mounjaro© treatment for more than two consecutive injections...
The study team makes the final eligibility decision.
Where it's taking place
- Ariel, Israel
- Petah Tikva, Israel
- Tel Aviv, Israel
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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ariel, Israel; Petah Tikva, Israel; Tel Aviv, Israel. 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.