ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metformin
Metformin 1.7-2.5mg per day during twelve weeks
Intervention: Biguanide, DPP4 inhibitors, SGLT2 inhibitors (Drug)
Metformina + IDDP-4
Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day
Intervention: Biguanide, DPP4 inhibitors, SGLT2 inhibitors (Drug)
Metformina + ISGLT-2
Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day
Intervention: Biguanide, DPP4 inhibitors, SGLT2 inhibitors (Drug)
Outcomes
Primary Outcomes
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
Time Frame: Baseline and week twelve
Bioimpedance is a confident method to measured visceral fat
Secondary Outcomes
No secondary outcomes reported
Investigators
Alonso Alberto Castro Arguelles
Metabolic Research Unit
Metabolic Research Unit