Semaglutide and Physical Activity for Obesity and Multimorbidity

Obesity Clinical Trial

Official title:

Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234111
• Other study ID #: F-23061071
• Status: Recruiting
• Start date: February 20, 2024
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: Hvidovre University Hospital
• Contact: Rasmus H Brødsgaard, MSc
• Phone: 004530896554
• Email: rasmus.hoxer.broedsgaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this observational study is to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary Semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity. This study is explorative and therefore does not include hypothesis testing.

Description:

This study is part of the project "Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare". 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: November 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI = 35

At least one of the following obesity-related comorbidities:

• Type II diabetes
• Resistant hypertension
• Sleep apnea
• Desire to become pregnant and fertility problems (in women only)
• Severe osteoarthritis of the lower extremities

At least one of the following contraindications for bariatric surgery:

• Substance abuse
• Eating disorder
• Developmental/cognitive disabilities where the patient is not expected to adhere to the necessary lifestyle changes after surgery
• Comorbidities that increase the risk associated with surgery
• Severe mental illness
• Inability to independently achieve an 8 % weight loss

Exclusion Criteria:

• Inability to give informed consent

Related Conditions & MeSH terms

• Multimorbidity
• Obesity
• Obesity Morbid

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Hvidovre	Hvidovre	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight	The patients' body weight will be measured and presented as mean percentual change in weight between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Other	Waist circumference	Waist circumference will be measured in cm with 1 decimal with a tape measurer and presented as mean change between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Other	Health-related quality of life: mental	The 36-Item Short Form Survey (SF-36) questionaire will be administered for all patients. The mental component summary score and its associated domain scores (vitality, social functioning, role-emotional, mental health) will be presented as the mean change between baseline, four months, and follow-up scores. Possible scores range from 0 to 100, with higher scores indicating better health status.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Other	Weight bias internalization	The Weight Bias Internalization Scale (WBIS) will be administered for all patients. The WBIS includes 19-items to be rated on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree". The mean score of all 19 items will be calculated and presented as mean change between baseline, four months, and follow-up. Possible mean scores range from 1 to 7, with higher scores indicating greater weight bias internalization.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Other	Cardiorespiratory fitness	Maximal oxygen uptake (VO2max) will be measured with the "Seismofit System". The Seismofit sensor is placed on the sternum, where it measures seismocardiography (the vibrations generated by the heart and transmitted through the chest). These measures are coupled with information on sex, age, weight, and height. Using an algorithm, the Seismofit System then estimates VO2max. Change in VO2max will be presented as mean change between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Other	Lower body strength	Lower body strength and endurance will be measured with the 30-Seconds Sit-To-Stand test and will be presented as mean change in repetitions between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Other	Walking capacity and endurance	Walking capacity and endurance will be measured with the 6-Minute Walk Test and will be presented as mean change in meters walked between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Primary	Habitual physical activity	SENS Motion accelerometry will be used to measure habitual physical activity, defined as time spent non-sedentary and not lying down. We will measure for seven full days. Data will be presented as mean change in hours/day spent physically active between baseline, four months, and follow-up.; As mentioned, the study is exploratory and designed with a flat outcome hierarchy and multiple evenly valued outcome measures. The registration template requires that one outcome is listed as "primary", which is why this one is listed. This does not mean we consider this outcome more important than other outcomes.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Secondary	Health-related quality of life: physical	The 36-Item Short Form Survey (SF-36) questionaire will be administered for all patients. The physical component summary score and its associated domain scores (physical functioning, role-physical, bodily pain, general health) will be presented as the mean change between baseline, four months, and follow-up scores. Possible scores range from 0 to 100, with higher scores indicating better health status.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Secondary	10-years cardiovascular risk (previous cardiovascular disease)	The 10-years risk of myocardial infarction, stroke or cardiovascular death wil be calculated using the SMART risk assessment tool. This specific risk assessment tool will be used only for individuals with previous cardiovascular disease, as it was designed for this particular population. All data needed for the SMART risk assessment tool are already being collected as routine practice. Results derived from the three different risk assessment tools will be combined, as they measure the exact same outcome (10-years cardiovascular risk). They will be presented as mean change in absolute risk between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
Secondary	10-years cardiovascular risk (type 2 diabetes)	The 10-years risk of myocardial infarction, stroke or cardiovascular death wil be calculated using the ADVANCE risk assessment tool. This specific risk assessment tool will be used for individuals with type 2 diabetes and without previous cardiovascular disease, as it was designed for this particular population. All data needed for the ADVANCE risk assessment tool are already being collected as routine practice. Results derived from the three different risk assessment tools will be combined, as they measure the exact same outcome (10-years cardiovascular risk). They will be presented as mean change in absolute risk between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
Secondary	10-years cardiovascular risk (apparently healthy)	The 10-years risk of myocardial infarction, stroke or cardiovascular death wil be calculated using the SCORE2 risk assessment tool. This specific risk assessment tool will be used for individuals without type 2 diabetes and previous cardiovascular disease, as it was designed for this particular population. All data needed for the SCORE2 risk assessment tool are already being collected as routine practice. Results derived from the three different risk assessment tools will be combined, as they measure the exact same outcome (10-years cardiovascular risk). They will be presented as mean change in absolute risk between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).