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

Phase 1

• Conditions: Abdominal fat layers in type 2 diabetic patients; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-000979-16-ES
• Lead Sponsor: Dr. Guillem Cuatrecasas - CPEN S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

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
F.1.3.1 Number of subjects for this age range 44

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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified