The effect of Semaglutide on diabetes incidence and prevention in patients with in neuroleptica-related prediabetes.

Phase 1

Conditions: Prediabetes and metabolic syndrome in SGA(second generation of antipshychotic treatment)-treated young adults with schizophrenia.
MedDRA version: 24.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861
MedDRA version: 23.0Level: PTClassification code 10052066Term: Metabolic syndromeSystem Organ Class: 10020638 - Hyperglycaemic conditions NEC
MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2020-004374-22-DK

Lead Sponsor: Steno Diabetes Center Odense

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 154

Inclusion Criteria

Inclusion criteria
•Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25)
•Age between 18 and 60 years (both included)
•Treated by one of the OPUS teams in the Region of Southern Denmark or Zealand
•Stable 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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
•Alcoholism (>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
•Participation in other drug trials
•Circumstances that the investigator believes will interfere with the trial