EUCTR2020-004374-22-DK进行中（未招募）1 期
HISTORIHome-based Intervention with Semaglutide Treatment OfNeuroleptica-Related Prediabetes The effect of Semaglutide on diabetes incidence and prevention in patients with in neuroleptica-related prediabetes. - HISTORI - Home-based Intervention with Semaglutide Treatment Of
Steno Diabetes Center Odense0 个研究点目标入组 154 人开始时间: 2020年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
2 期
Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related PrediabetesPrediabetic StateSchizophreniaNCT05193578Jan Frystyk154
招募中
1 期
A research study to look into how semaglutide, together with a lower dose of insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetes (SUSTAIN OPTIMIZE)CTIS2024-510612-75-00ovo Nordisk A/S568
进行中（未招募）
1 期
A research study to look into how well semaglutide, together with insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetesDiabetes Mellitus, type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2021-004392-13-ESovo Nordisk A/S568
进行中（未招募）
1 期
A research study to look into how well semaglutide, together with insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetesDiabetes Mellitus, type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2021-004392-13-SKovo Nordisk A/S568
进行中（未招募）
1 期
A research study to look into how well semaglutide, together with insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetesDiabetes Mellitus, type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2021-004392-13-GRovo Nordisk A/S568