MedTrace Logo

Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

NCT02104739 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-07-03

Study results available
· View outcomes & findings →

Summary

This project addresses cardiovascular disease risk in patients with prediabetes. Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism. These medications will be studied for their effect in reducing both postprandial lipid levels and arterial dysfunction.

Conditions

Interventions

DRUG

Exenatide

Single subcutaneous injection (10 mcg)

DRUG

Saxagliptin

Single dose orally (5 mg)

DRUG

Exenatide extended-release (ER)

Subcutaneous injection (2mg) weekly for 6 weeks

OTHER

Placebo

Placebo tablets and Placebo (normal saline) injections

Sponsors & Collaborators

  • The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Absalaon D Gutierrez, MD · University of Texas Health Science Center at Houston, Dept. of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-03-31
Completion
2017-03-31
FDA Drug
Yes

Countries

  • United States

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 NCT02104739 on ClinicalTrials.gov