Clinical trial NCT05032001: ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT
Official title: ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Obesity
Type 2 Diabetes
Lead sponsor: Metabolic Research Unit
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
timeFrame: Baseline and week twelve
Secondary outcomes:
Other outcomes:
measure: Change from baseline in A1c level at week twelve
timeFrame: Baseline and week twelve
Locations:
city: San Luis Potosi
country: Mexico
facility: Metabolic Research Unit
Study officials:
References:
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