ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

Metabolic Research Unit

Status: Unknown

Conditions: Abdominal Obesity; Type 2 Diabetes

Treatments: Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Study type: Interventional

Funder types: Industry

Identifiers

NCT05032001

protocol1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Metformin

Experimental group

Description:

Metformin 1.7-2.5mg per day during twelve weeks

Treatment:

Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Metformina + IDDP-4

Experimental group

Description:

Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day

Treatment:

Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

Metformina + ISGLT-2

Experimental group

Description:

Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day

Treatment:

Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors