ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT

September 1, 2021 updated by: Alonso Alberto Castro Arguelles, Metabolic Research Unit

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78218
        • Metabolic Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and week twelve

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in A1c level at week twelve
Time Frame: Baseline and week twelve
Glycated hemoglobin percentage is the most reliable method to explain glycemic control in type 2 diabetes patients
Baseline and week twelve

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metabolic Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2021

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (ACTUAL)

September 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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