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临床试验/CTIS2024-513416-98-00
CTIS2024-513416-98-00进行中(未招募)1 期

Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide (DiaSpax)

Karolinska University Hospital0 个研究点目标入组 60 人开始时间: 2024年5月29日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • The participant has provided written consent to participate in the study, Age 30-70, BMI =25, 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, 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, Insulin treatment, Waran or NOAK-treatment, Pregnancy, nursing or planned pregnancy, Ongoing pregnancy (positive pregnancy test), Positive GAD or IA2 antibodies (Above reference range)

研究者

发起方
Karolinska University Hospital

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