ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

Study Overview
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Brief Summary
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Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Quantification of visceral fat with bioimpedance (BIA) is closely related to measurement with computed axial tomography. Different available oral antidiabetics cause weight loss and total body fat (biguanides, DPP-4 inhibitors and SGLT-2 inhibitors), but it has only been shown that SLGT2 inhibitors decrease visceral fat. Therefore, the aim of this study is to determine whether there is a difference in the amount of visceral fat measured with BIA in T2D patients between three oral antidiabetic regimens after twelve weeks of treatment, to compare the effect on visceral fat between metformin, DPP4 inhibitors and SGLT2 inhibitors.

Official Title
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ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.

Conditions
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Abdominal Obesity, Type 2 Diabetes

Intervention / Treatment
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* Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients +18 years Patients with visceral fat quantification by BIA at baseline and week twelve Patients with body mass index >25 Patients can swallow tablets Exclusion Criteria: Patients treated with other oral antidiabetic agents or insulin Glomerular filtration rate less than 30 mL/min Transaminemia greater than 2 times the upper reference value Pregnancy Malnutrition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Metformin 1.7-2.5mg per day during twelve weeks | Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors<br>* Oral antidiabetic treatment during twelve weeks<br>|
| Experimental: Metformina + IDDP-4<br>Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day | Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors<br>* Oral antidiabetic treatment during twelve weeks<br>|
| Experimental: Metformina + ISGLT-2<br>Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day | Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors<br>* Oral antidiabetic treatment during twelve weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve | Bioimpedance is a confident method to measured visceral fat | Baseline and week twelve |