Semaglutide and Physical Activity for Obesity and Multimorbidity
NCT ID: NCT06234111
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
35 participants
OBSERVATIONAL
2024-02-20
2026-11-30
Brief Summary
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This study is explorative and therefore does not include hypothesis testing.
Detailed Description
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While this observational quantitative study aims to provide a comprehensive description of changes in patients' health and wellbeing during and after participation in weight loss treatment, the project also includes a qualitative interview study with a subset of patients from the same population to supplement and expand upon the quantitative findings. Additionally, a smaller subgroup of patients from the same population will eventually be invited to actively contribute to the collaborative development of a physical activity intervention in a co-design process, drawing on insights from the aforementioned studies.
Given its exploratory approach, the study is designed with a flat non-hierarchical outcome structure and multiple evenly valued outcomes measures. This will be reported evenly for all outputs of this research.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with severe obesity and multimorbidity
Patients with morbid obesity (mainly class II and III) with multiple chronic conditions. Most patients are initially referred for bariatric surgery, but are deemed ineligible for various reasons (typically inability to independently induce weight loss, severe mental disease, eating disorder, and serious comorbidity).
Semaglutide 2.4 mg, total diet replacement, behavioural intervention
Patients receive a highly specialized interdisciplinary weight loss treatment comprising two phases. Firstly, they engage in a total diet replacement using Nupo for approximately three months to induce a maximal weight loss. After this and for the duration of the entire treatment period, patients receive Semaglutide 2.4 mg and behavioural dietary support to maintain the weight loss and improve health. The total treatment period is two years.
Interventions
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Semaglutide 2.4 mg, total diet replacement, behavioural intervention
Patients receive a highly specialized interdisciplinary weight loss treatment comprising two phases. Firstly, they engage in a total diet replacement using Nupo for approximately three months to induce a maximal weight loss. After this and for the duration of the entire treatment period, patients receive Semaglutide 2.4 mg and behavioural dietary support to maintain the weight loss and improve health. The total treatment period is two years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 35 kg/m2
* Aged ≥ 18 years
* One or more obesity-related conditions (type II diabetes, resistant hypertension, sleep apnea, severe osteoarthritis of the lower extremities)
* One more comorbidities that prevent bariatric surgery
Exclusion Criteria
* Inability to understand Danish
* Cognitive impairments
UPDATE 17.09.2024:
After initiating patient recruitment for the study on 15.02.2024, the project group identified discrepancies between the eligibility criteria and description of the study population as originally reported in the trial registration and those actually applied in the study. As a result, we adjusted both the eligibility criteria and description of the study population in the trial registration on 17.09.2024. These adjustments do not represent a change in the actual patient population but rather offer a more accurate and consistent description of their characteristics.
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Rasmus Hoxer Brødsgaard
Principal Investigator
Principal Investigators
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Rasmus H Brødsgaard, MSc
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Hvidovre
Locations
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Copenhagen University Hospital, Hvidovre
Hvidovre, Capital Region, Denmark
Countries
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Other Identifiers
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F-23061071
Identifier Type: -
Identifier Source: org_study_id