2024-513416-98-00招募中2 期
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide (DiaSpax)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Lipolysis is measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from the subcutaneous abdominal periumbilical adipose tissue and expressed as log10 ISO-stimulated/basal glycerol release ex vivo
研究概览
简要总结
How do various antidiabetic drugs differ in their beneficial effects on adipose tissue function?
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The participant has provided written consent to participate in the study
- •HbA1c ≥42 mmol/mol
- •Fertile women must use effective contraception throughout the study. Effective contraception includes any of the following: Combined hormonal contraceptives (estrogen and progestogen) that inhibit ovulation: oral, intravaginal, or transdermal; Progestogen-only contraceptives that inhibit ovulation: oral, injectable, or implantable; Intrauterine device (hormonal or copper); Bilateral tubal occlusion; Vasectomized partner; Sexual abstinence (refraining from heterosexual intercourse throughout the study). Women of childbearing potential need a negative pregnancy test at screening before randomization.
排除标准
- •HbA1C ≥ 65 mmol/mol
- •Insulin treatment
- •Waran or NOAK-treatment
- •Pregnancy, nursing or planned pregnancy
- •Ongoing pregnancy (positive pregnancy test)
- •Positive GAD or IA2 antibodies (Above reference range)
- •Hypersensitivity to the active substance or any of its excipients
- •History of bladder cancer
- •Uninvestigated macroscopic hematuria
- •Low C-peptide/glucose ratio indicative of endogenous insulin deficiency (less than 2 measured as pmol/mg per dL)
- •NT-proBNP 20% above the normal reference value
- •Kidney disease/impairment (eGFR <60 ml/min)
- •Liver disease and/or impairment (hepatic values over twice the upper reference value)
- •Other severe chronic illness including ongoing cancer
- •Established cardiovascular disease and/or heart failure
- •Severe psychiatric condition
- •Active alcoholism
结局指标
主要结局
Lipolysis is measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from the subcutaneous abdominal periumbilical adipose tissue and expressed as log10 ISO-stimulated/basal glycerol release ex vivo
Lipolysis is measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from the subcutaneous abdominal periumbilical adipose tissue and expressed as log10 ISO-stimulated/basal glycerol release ex vivo
次要结局
- The cellular heterogeneity of adipose tissue (i.e., different adipocyte subtypes) is measured using qPCR of ADIPOQ/LEP in the same adipose tissue samples from which lipolysis is measured.
研究者
Principal Investigator
Scientific
Karolinska University Hospital
研究点 (3)
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