Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether the Glucagon Like Peptide 1 (GLP-1) Semaglutide (1.34 mg/ml) has preventive effect compared to placebo in the development of diabetes and Metabolic Syndrome in people with pre-diabetes, overweight and schizophrenia, who receive antipsychotic treatment.

Furthermore to investigate for an effect of Semaglutide compared to placebo on psychotic symptoms and quality of life in people with schizophrenia, prediabetes and overweight.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jan Frystyk
• Collaborators: Region of Southern Denmark; Region Zealand; Steno Diabetes Center Odense; Steno Diabetes Center Sjaelland

Criteria

Inclusion Criteria:

• Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25)

• Age between 18 and 40 years (both included)

• Approved contraception for female participants

• Treated by one of the OPUS clinics and or community psychiatry centers teams and community psychiatry in the Region of Southern Denmark or Zealand

• Antipsychotic SGA treatment for at least 6 months

• Stable co-medication for at least 1 month

• HbA1c between 39-47 mmol/mol (both included). Two measurements with ≥3 month interval are required to confirm prediabetes. The first measurement is identified and obtained from patient journals, the second prior to enrolment

• BMI ≥27 kg/m2. Two weights with ≥3 month interval are required to confirm obesity

• Capable of providing informed oral and written consent

Exclusion Criteria:

• Diagnosis of diabetes (T1D or T2D) or a HbA1c >47 mmol/mol

• Active malignant disease within the last 5 years

• Pregnancy or breast feeding

• Exceeding high risk consumption limit (>21 / 14 units of alcohol for men / women, respectively) or severe substance abuse

• Unwillingness to allow home visits by a study nurse

• Significant somatic disease: 1) end-stage renal failure (eGFR <15 ml/min); 2) elevated liver function tests (liver transaminases >2 times upper normal limit); 3) history of acute or chronic pancreatitis; 4) heart failure (NYHA class IV) or unstable angina pectoris or myocardial infarction with the last 6 months; 5) uncontrolled hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure >100 mm Hg)

• Previous treatment with study drug or use of other weight reducing drugs within the last 6 month

• Participation in other drug trials

• Treatment with drugs approved for overt diabetes type 2. (Metformin not included)

• Circumstances that the investigator believes will interfere with the trial