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Effect of Linagliptin on TRL Metabolism

NCT02280174 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-04

No results posted yet for this study

Summary

Overproduction of intestinally derived triglyceride-rich lipoproteins (TRLs) (chylomicrons) has recently been described in type 2 diabetes (T2DM), as is known for hepaticTRL (very-low-density lipoprotein) production.

There is an interest in identifying therapies that would favourably influence postprandial concentrations of lipids in T2DM.

linagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function.

Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-IV inhibitor treatment, animal studies suggested that DPP-IV inhibition reduce intestinal triglycerides (TG) absorption and apolipoprotein (apo) production and increased chylomicron catabolism. Interestingly, a recent study supporting this hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal TRL particles in patients with type 2 diabetes. Recently, it had reported that sitagliptin treatment significantly reduced plasma apoB-48 and TG concentrations in the postprandial state.

The action of DPP-IV inhibitors may be explained by insulin secretion or action of glucagon-like peptide (GLP-1) on metabolism of TRL.

Therefore, the present study was designed to examine the effects of linagliptin treatment (LT) vs standard treatment (ST) on the metabolism of TRL apoB-48 in patients with type 2 diabetes over a 12 weeks-period.

The investigators will study the patients in three different moments defined as: Time 0 (2 weeks before LT or ST, Time 1 (4 weeks after LT or ST), Time 2 (12 weeks after LT or ST). With areas under the curve (AUCs) of apoB48 in postprandial conditions.

Conditions

Interventions

DRUG

linagliptin

linagliptin 5 mg/d for12 weeks

Sponsors & Collaborators

  • Aix Marseille Université

    collaborator OTHER

  • Instituto de Biología y Medicina Experimental, IBYME, Buenos Aires, Argentina

    collaborator UNKNOWN

  • Ministry of Public Health, Argentina

    lead OTHER_GOV

Principal Investigators

  • Juan Nogueira, MD/PhD · Medico Moving Center Institute, Formosa, Argentina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-11-30
Completion
2016-10-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280174 on ClinicalTrials.gov