EUCTR2019-000979-16-ES
Active, Not Recruiting
Phase 1
Dapagliflozin effect in the reduction of different abdominal fat layers in type 2 diabetic patients. - OMENDAPA
Dr. Guillem Cuatrecasas - CPEN S.L.0 sites88 target enrollmentJune 11, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr. Guillem Cuatrecasas - CPEN S.L.
- Enrollment
- 88
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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