Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2GW, United Kingdom
NCT Number: NCT07602803
The goal of this observational study is to learn about the long-term effects of GLP1 agonists (weight loss jab, including Mounjaro) in patients with Bardet-Biedl Syndrome (BBS) who take GLP1 agonists to treat high body weight. The main question:
Do GLP1 agonists effectively and safely lower body weight in patients with BBS when taken long-term, compared to patients not on these medications? The investigators look at the change (%) in weight during the observational periods.
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Notify Me18 year and older
All sexes
Observational
Birmingham, West Midlands, B15 2GW, United Kingdom
Demographics on time zero: Age, gender, Race, Body Weight (BW), Body Mass Index (BMI), Blood Pressure (clinic, DM meds), Pulse, Lipid profiles (Chol, HDL, LDL, TG), eGFR, HBA1c, (if feasible) genetic diagnosis
Primary outcome at the end of study date : Body weight change (%)
Secondary outcome at the end of study date: change in lipid (Chol, HDL, LDL, TG), Blood Pressure, DM status
Quality assurance plan: data validation will be secured due to the electronic record. The registry process was undertaken in our closed national BBS centres quality assured by multi-disciplinary team (MDT) looked after by senior specialty nurses, who followed all the patients with GLP1 agonists monthly over the telephone.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources.
Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results: The investigators followed all the missing data by contacting patients' family doctors (GP) and their records.
Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrolment to the end of treatment at the end of study date up to 18 months
Change (%) of Body weight (kg) from BW at the start date of this study and BW at the end of study date
The Queen Elizabeth Hospital
Other
GLP1 Agonists Once Weekly for the Treatment of Obesity in Patients With Bardet-Biedl Syndrome (BBS)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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