Clinical trial

Semaglutide and Physical Activity for Obesity and Multimorbidity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06234111

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity Morbid, Multimorbidity, Obesity

Full registry criteria

Study participants are recruited from a particular interdisciplinary weight loss program based at Copenhagen University Hospital Hvidovre. Hence, the study uses the same set of inclusion criteria: Inclusion criteria: * Fulfilment of the Danish criteria for bariatric surgery: * 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 are: * Unwillingness to participate in the study * 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.

Treatments and study arms

Semaglutide 2.4 mg, total diet replacement, behavioural intervention

Combination Product

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.

Primary outcomes

Habitual physical activityBaseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Copenhagen University Hospital, Hvidovre🇩🇰 Hvidovre, Capital Region, Denmark

Open map