Effectiveness of Sitagliptin for HIV Insulin Resistance and Inflammation
|ClinicalTrials.gov Identifier: NCT01552694|
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : March 5, 2015
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Macrophage Infiltration Cardiovascular Disease||Drug: Sitagliptin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double Blind, Randomized, Placebo Controlled Study to Determine the Physiological Effectiveness of Januvia for Reducing Inflammation and Increasing EPC Number in HIV Infected Men and Women With Insulin Resistance and Central Adiposity.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
100 mg sitagliptin/day for 2 months
Oral, 100 mg/day for 2 months
Other Name: Januvia
Placebo Comparator: Placebo
Matching placebo daily for 2 months
oral, matching placebo daily for 2 months
- Inflammatory Biomarker 1: Plasma hsCRP Concentration [ Time Frame: 2 months ]Fasting serum and plasma samples obtained at baseline and week 8 are batched for ELISA analysis (end of sudy) of hsCRP, IL-6 and D-dimer concentrations.
- Inflammatory Biomarker 2: Plasma IL-6 Concentration [ Time Frame: 2 months ]There are 3 levels of the primary outcome measure; hsCRP, IL-6, and D-dimer concentrations measured at baseline and week 8
- Inflammatory Biomarker 3: Serum D-dimer Concentration [ Time Frame: 2 months ]There are 3 levels of the primary outcome measure, hsCRP, IL-6, and D-dimer
- Adipose Inflammation [ Time Frame: 2 months ]Adipose tissue from obese, insulin resistant subjects is characterized by increased macrophage infiltration and overexpression of inflammatory cytokines/chemokines. In obese humans, the presence of CD68+ macrophages in direct contact with mature adipocytes has been noted in histologic sections of adipose tissue, and these appear as a macrophage "crown" around individual adipocytes. In adipocyte sections, we will use positive immunohistochemical staining for CD68 to quantify the density of macrophages and the frequency of "crown' like structures.
- Blood Endothelial Progenitor Cells [ Time Frame: 2 months ]Monocytes are isolated from 20 mL blood. CD34+/VEGFR2+ and CD133+/CD34+/VEGFR2+ monocytes are counted (flow cytometry) and represent markers for endothelial progenitor cell number.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552694
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Kevin E Yarasheski, PhD||Washington University School of Medicine|