Status:
COMPLETED
Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes
Lead Sponsor:
Jan Frystyk
Collaborating Sponsors:
Region Zealand
Region of Southern Denmark
Conditions:
Schizophrenia
Prediabetic State
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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-d...
Detailed Description
Quality control: Usual quality control procedures will be followed in accordance with the ICH Guideline for Good Clinical Practice (GCP). The GCP unit at OUH will be responsible for monitoring the st...
Eligibility Criteria
Inclusion
- Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25)
- Age between 18 and 60 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05193578
Start Date
January 1 2022
End Date
May 1 2024
Last Update
July 8 2024
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark