Prediabetes and metabolic syndrome in SGA(second generation of antipshychotic treatment)-treated young adults with schizophrenia. MedDRA version: 24.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861 MedDRA version: 23.0 Level: PT Classification code 10052066 Term: Metabolic syndrome System Organ Class: 10020638 - Hyperglycaemic conditions NEC MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175
Conditions
Interventions
Trade Name: Ozempic
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: Ozempic
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration unit: mg/ml m
Sponsors
Steno Diabetes Center Odense
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: GLP-1 analog is known for its beneficial effect on diabetes patients by reducing HbA1c, contributing weight loss, and preventing cardiovascular death. The hypothesis of this trial is that administration of Semaglutide 1.34 mg/ml (Ozempic®) for 30 weeks improves HbA1c (primary outcome) in SGA-treated young adults with schizophrenia suffering from prediabetes (HbA1c between 37 and 47 mmol/mol) and having a BMI =27 kg/m2, when compared against placebo. Additionally, that Semaglutide improves the following secondary endpoints: weight, quality of life measures, patient-related outcomes (PRO data) and the cardiometabolic risk factor profile. Primary Outcome: Changes in HbA1c after 30 weeks of treatment. ;Secondary Objective: BMI and waist circumference will be measured using standard techniques and equipment each month. Positive and Negative Symptom Scale (PANSS) is used for measuring symptom severity of patients with schizophrenia. Impact of Weight on Quality of Life-Lite (IWQOL-Lite) PRO-data: Brief questionnaires (5-8 items each) concerning distress, food craving, physical activity and social function. Modifiable cardiovascular risk markers: PET/CT imaging: We want to perform a pilot study in a subsample, focusing on pre-symptomatic atherosclerosis assessed by positron emission tomography/computed tomography (PET/CT) using 18F-sodium fluoride (NaF) as tracer. Screening for cardiovascular autonomic neuropathy (CAN). Markers of adipose tissue homeostasis. Markers of CVD. Insulin sensitivity regulates the insulin-like growth factor (IGF) system. ;Primary end point(s): Primary end point for the study will be changes in HbA1c. Changes in HbA1c will be evaluated after three months and after 6 months. A mixed effects linear regression analysis is used to compare changes in glucose tolerance, HbA1c, from baseline to six months’ follow-up between the intervention and the placebo groups. ;Timepoint(s) of evaluation of this end point: Changes in HbA1c will be | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: After 30 weeks of treatment. a)Metabolic measures: BMI, blood pressure, triglyceride, cholesterol (HDL and LDL) and waist circumference and HOMA-estimates based on fasting insulin and plasma glucose. b)Quality of life measures, using standardized questionnaires such as Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite). c)Psychotic symptoms and SGA adherence measures, using the Positive and Negative Syndrome Scale (PANSS) and measurement of adherence to SGA by the Antipsychotic Medication Beliefs and Attitudes Scale (AMBAS) d)PRO-data, using questionnaire-based assessment of distress (Kessler's 10-item psychological distress scale, food craving (Yale Food Addiction Scale (YFAS)), physical activity, the Simple Physical Activity Questionnaire (SIMPAQ) and overall function, Work and Social Adjustment Scale (WSAS). e)User perspectives, assessed through semi-structured interviews with 26 patients purposely sampled to cover the variability among subjects, focusing on 1) how SGA-treated patients experience the addition of a treatment requiring weekly injections; 2) what possible changes in everyday routines, mental and physical well-being do the patients experience during the intervention, and finally; 3) what opinions do the patients have concerning possible future pharmacological prevention coupled with treatment with anti-psychotic medication. Cardiovascular risk markers: pro-atherosclerotic changes as measured by NaF-PET/CT, cardiovascular autonomic neuropathy (CAN), and circulating levels of cardiovascular biomarkers. ;Timepoint(s) of evaluation of this end point: Secondary endpoints: After 30 weeks of treatment. a) Metabolic measures: BMI, blood pressure. Every 4th. week. b) Beginning and end og trial: Triglyceride, cholesterol (HDL and LDL)and HOMA-estimates based on fasting insulin and plasma glucose, cardiovascular risk markers. c) Every 4.th week: Quality of life measures. d) Pre study, at week 1 | — |
Countries
Denmark
Contacts
Public ContactAshok Ganeshalingam
Steno diabetes Center OUH
Outcome results
None listed