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An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore whether Saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in Denmark. We wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liraglutide 3 mg (Saxenda®) once-daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide 3 mg (Saxenda®) once-daily | Drug | Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. The injection is administered subcutaneously. The initial daily dose will be 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached (week 1: 0.6 mg, week 2: 1.2 mg, week 3: 1.8 mg, week 4: 2.4 mg, week 5-26: 3.0 mg. If necessary, a longer titration period is accepted). If the lowest tolerated dose is less than 1.8 mg of liraglutide (Saxenda®) once-daily after 12 weeks from inclusion, the patient will be excluded from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the number of "completers" | Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reason(s) for drop-out | The reason for withdrawal may be the withdrawal of consent, any use of coercive measures, failure to maintain a present level of compliance with the clinical trial medication | 26 weeks |
| Changes in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark. | Roskilde | 4000 | Denmark |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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An open-label, multi-centre, 26-weeks clinical feasibility study
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|
Kg
| 26 weeks |
| HbA1c | mmol/mol | 26 weeks |
| blood pressure | mmHg | 26 weeks |
| heart rate | Beats/minute | 26 weeks |
| FIB-4 score | index | 26 weeks |
| lipid profile | mmol/L | 26 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |