Abdominal fat layers in type 2 diabetic patients
Conditions
Interventions
Trade Name: Metformin
Pharmaceutical Form: Tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
Other descriptive name: Metformin
Concentration unit: mg milligram(s)
Concentration type: range
Concentra
Sponsors
Dr. Guillem Cuatrecasas - CPEN S.L.
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the differences between both arms of treatment (metformin vs. metformin + dapagliflozin) regarding omental fat layer reduction after 6 months of treatment.;Secondary Objective: - Correlation between thickness of omental layer and cardiovascular risk measurements and comparisons between both arms of treatment. - Percentage of patients who were able to reduce their omental fat under 37 mm (females) and 54 mm (males) after 6 months of treatment. - Evaluate the changes in the thickness of the different abdominal fat layers to be analysed and compare the results between treatment arms. - Identify other potential layers of abdominal fat (e.g. pre-peritoneal) that may correlate with glycaemic control (HbA1c), clinical criteria for metabolic syndrome, or cardiovascular risk markers.;Primary end point(s): Measurement of omental fat layer (mm thickness) through Abdominal Ultrasound (AU) at baseline and 6 months after treatment initiation, and comparisons in terms of reduction between both treatment arms.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 6 months;Timepoint(s) of evaluation of this end point: - Analyze the presence of metabolic synd and comparison between groups -Analyze the insulin resistance of study population and comparison between groups - Analysis of reduction of the omental fat layer after 6 months of treat and it´s correlation with the following measurements - Achievement of omental fat layer levels under 37 mm (F) and 54 mm (M) through AU and comparisons between groups - Measurement of the different abdominal fat layers through AU at baseline and 6 months after treat initiation, and comparisons between groups - Correlation between the thickness of the different abdominal fat layers and total fat mass/BMI and comparisons between groups - Correlation between thickness of different abdominal layers with cardiovascular risk measurements and comparisons between groups | — |
Countries
Spain
Contacts
Public ContactDr. Guillem Cuatrecasas
CPEN S.L.
Outcome results
None listed