Semaglutide and Physical Activity for Obesity and Multimorbidity

NCT06234111 | Active Not Recruiting

• 1 other identifier: F-23061071
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity Morbid; Multimorbidity; Obesity

Keywords

Obesity; Multimorbidity; Semaglutide; Glucagon-like peptide-1 receptor agonist; Physical activity; Exercise; Co-design; Patient-centred; Cardiometabolic health; Health-related quality of life; Wegovy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health-related quality of life: physical

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

• 10-years cardiovascular risk (previous cardiovascular disease)

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

• 10-years cardiovascular risk (type 2 diabetes)

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

• 10-years cardiovascular risk (apparently healthy)

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

Other Outcomes (7)

• Body weight

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

• Waist circumference

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

• Health-related quality of life: mental

  Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

Study Arms (1)

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).

Combination Product: Semaglutide 2.4 mg, total diet replacement, behavioural intervention

Interventions

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.

Also known as: Wegovy, Nupo, Dietary counseling

Patients with severe obesity and multimorbidity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals living in the Capital Region of Denmark can be referred to the weight loss program if they fulfill the Danish criteria for bariatric surgery while having comorbidities that increase the risk of surgery or challenge the accompanying necessary lifestyle changes, thereby making them ineligible for bariatric surgery. Consequently, most patients in the weight loss program are severely burdened by high levels of obesity (usually BMI \> 40 kg/m2) and have debilitating somatic and mental multimorbidity (corresponding to Edmonton Obesity Staging System stages 2-4). In other words, patients for whom a substantial and sustained weight loss is expected to lead to tangible and significant health benefits.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, Capital Region, 2650, Denmark

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Motor Activity

Interventions

semaglutide; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rasmus H Brødsgaard, MSc

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 31, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)