Dapagliflozin effect in the reduction of different abdominal fat layers in type 2 diabetic patients. - OMENDAPA

Dr. Guillem Cuatrecasas - CPEN S.L.0 个研究点目标入组 88 人开始时间: 2019年6月11日最近更新: 2023年10月9日

研究概览

暂无简介。

•1. Patients of both sexes between the ages of 50 and 75 (both included) at the time of signature of informed consent form.
•2. Diagnosed of type-2 diabetes (defined as HbA1c level between6.5% and 9%) a maximum of 12 months prior to Informed Consent form signature.
•3. Treatment naive Patients (only diet and exercise as current treatments for glycemic control are permitted)
•4. BMI >30kg/m2 at baseline visit.
•5. Patients omental fat over 37 mm (females) and 54 mm (males) at baseline visit
•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 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•1. Not able or unwilling to sign the Informed Consent form.
•2. Other serious illness that according to Investigator criteria could compromise the patient follow-up during the study
•3. Patient is unable of follow the hypocaloric diet with a -500 Kcal/day deficiency.
•4. Previous use of other antidiabetic drugs
•5. Hepatic failure defined as:
•a. AST > 3X upper limits level compared to reference levels.
•b. ALT > 3X upper limits level compared to reference levels.
•c. Bilirrubin > 3X upper limits level compared to reference levels.
•6. Renal failure (defined as GF <60ml/min).
•7. Concomitant use of other diuretic drugs
•8. Recurrent Urinary Tract Infection (defined as more than 2 UTI´s in last year previous to inclusion)
•9. Women of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies
•10. A woman of childbearing potential must have a negative urine pregnancy test at screening within 10-14 days and 24 hours before commencing treatment. Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods for reliable birth control simultaneously.
•11. Simultaneous participation in a clinical trial for the duration of this study.

发起方

Dr. Guillem Cuatrecasas - CPEN S.L.