ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

Not Applicable

• Conditions: Type 2 Diabetes; Abdominal Obesity
• Interventions: Drug: Biguanide, DPP4 inhibitors, SGLT2 inhibitors

• Registration Number: NCT05032001
• Lead Sponsor: Metabolic Research Unit

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-09
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformina + IDDP-4	Biguanide, DPP4 inhibitors, SGLT2 inhibitors	Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day
Metformina + ISGLT-2	Biguanide, DPP4 inhibitors, SGLT2 inhibitors	Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day
Metformin	Biguanide, DPP4 inhibitors, SGLT2 inhibitors	Metformin 1.7-2.5mg per day during twelve weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve	Baseline and week twelve	Bioimpedance is a confident method to measured visceral fat

Trial Locations

Locations (1)

Metabolic Research Unit; 🇲🇽 San Luis Potosi, Mexico